chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection Site Pain; Nausea; Vomiting; Headache; been sick; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced sickness. On 23rd August 2019, the patient experienced injection site pain, nausea, vomiting and headache. On an unknown date, the outcome of the injection site pain, nausea, vomiting, headache and sickness were unknown.   It was unknown if the reporter considered the injection site pain, nausea, vomiting, headache and sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by an office manager at a physician's office who herself was a patient. The age at vaccination was not reported. The patient received Shingrix and she did not feel the same with the 2nd dose as she did with the 1st dose.  The patient indicated that has been so sick since receiving the vaccination. On 23rd August 2019, she called in sick and experienced nausea, vomiting, headache, and injection site pain the entire weekend. On 26th August 2019, the field representative received an email from the patient. On 27th August 2019, the GlaxoSmithKline representative called back stating that he followed up and patient and did not wish to be recontacted by GlaxoSmithKline regarding these events. The sales representative stated that he received an email requesting the name of the health care professional where the reported consumer received their Shingrix injection. The sales representative stated that he did not had that information as the person who reported the information was a manager at a facility he visits and just happened to be talking to her when she provided the information.  The reporter did not have additional information about the incident.
Headache, Myalgia, Bell's palsy symptoms started on 3/28/21, was Rx with prednisone, symptoms resolved s/p treatment.  Narrative:
reports hives under chin; This is a spontaneous case received from a contactable female consumer (patient). A female patient of unspecified age received first dose bnt162b2 (Pfizer's COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 22Feb2021 date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hives under chin after administration of the first dose. She wanted to know if this was normal side effects. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient was having much difficulty breathing.  We called clinic for help.  They advised us to give her Albuterol mist treatments.  We gave her 3x into the night.  They also advised us to give her Prednisone late in the evening, which we did.  Her breathing was in control an hour later.  She has been having trouble breathing every night since then.  We have been giving her breathing treatments every evening.  She has been on Prednisone on a daily basis.  11/20 and 11/23 Pediatrician records for 11/12/2009. Dx SOB  Patient with c/o's SOB and cough.Tx: steroids
Sustained slight but rapid muscle twitching in the deltoid muscle of the injection (left) arm. Noticable the afternoon of post injection day #1. Twitching continued for approximately 1 hour then ceased. No other side effects reported other than minimal arm soreness that didn't interfere with daily activity
subsequent to receiving first and second doses of varicella virus vaccine live the pt experienced fever. Two days later the pt experienced a rash with approximately 20 lesions generally on the trunk and a few on the extremities.
With the first two, I had similar symptoms that were common to the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.). At the time of the report, VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient post first dose had similar symptoms that were common to the vaccine.   This case was linked to MOD-2021-362728, MOD-2021-341009 (Patient Link).
pt stated that when she woke up today 3/2/2021 she had terrible aches all over her body and in her lymph nodes.  She has chills, headache, and flu like symptoms.  Pt has taken Tylenol for her symptoms but has not contacted her PCP at this time.
Mid-cycle menstrual bleeding (basically a full 7-day menstrual cycle that started one week after my regular cycle ended. ) Dr found no logical cause for this (no infection, no possible pregnancy, etc) other than possibly stress or pre-menopause but saw other women asking online if others had also experienced this and felt I should report it just in case there is a causal relationship. I have never had random cycles before.
Pfizer-BioNTech COVID-19 Vaccine EUA:  hospitalized for pulmonary embolism and COVID-19 infection after COVID-19 immunization. Received oxygen, anticoagulated, and discharged to home.
Right hand at the site of Injection Red, lightly swollen, hard and hot. She is experiencing slight pain. Redness over half of upper top portion of hand surrounding site of Injection and reporting soreness too.
Patient returned to the pharmacy 2 days after receiving her first dose of SHINGRIX and had a red area on her arm where the shot had been given (about 2-3 inches in diameter). Patient also reported having felt a bit sick to her stomach after receiving the shot.
Per the patient's son, the patient awoke in the middle of the night on 05/27/2021 and experienced an episode of "shaking" and "was unresponsive for a few seconds." The episode then resolved and the patient was transported by EMS to hospital services. The patient returned home the following day.
heaviness on chest, sore throat, cough, aches / pains, joints muscles, tried, cramping in lower legs, headaches (i couldnot think)
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-FEB-2014, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-JAN-2017, the patient was treated by a healthcare provider at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
MMR, Varc and Flu administered on 9/17/12 mother reported pt. developed rash and low grade temp 9/27/12-9/30/12. Rash at injection site of MMR and on abdomen only - red, prickly looking, not raised. Mom did not notify office until 10/16/12.
Every time I have a vaccine, I have worse and worse episodes of Graves Disease and Thyroid Eye Disease.   I have a record that I created showing cause and effect starting in 1995.  I did not realize there was cause and effect until 2009, when an episode occurred in December 2007 and an episode occurred in December 2009.  I realized I'd had a vaccine both years in October.  I went home and wrote down all the other dates of Graves Disease and Thyroid Eye Disease; then, I checked my vaccine records (I lived in country until March 29, 2003), and THEY ALL LINED UP.  The 2007 flu vaccine resulted in a thyroidectomy in December 2008 (because I hadn't yet made the connection), and the 2009 flu vaccine (I don't know which one) resulted in bilateral orbital decompression, bilateral eye muscle surgery, and eyelid surgery.
Hard bumps under the skin. Called nodules. Those were the first weird symptoms. At a softball game in May 2009, I had my first flare up. It stopped the game. I was doing so good that game on 3rd base. It was very hot and sunny. As we were coming into the dugout I felt my chest ears and cheeks burn up to a million degrees. They were beet red as were my eyes, bloodshot. I sat in the dugout everyone's asking me if I'm ok.. I was so confused and dazed I knew what people were saying but I couldn't talk back. Then I got a very severe stomach ache and had to be carried into the bathroom. Months later after lots of blood work and doctors appointments, I tested positive in every way for lupus.
COVID-19 Vacc MRNA (5-11yr) (Pfizer) 10 Mcg/0.2 Ml Im Susp (Orange) use for COVID-19 under Emergency Use Authorization (EUA) : Covid vaccine was not diluted properly resulting in wrong dose of vaccine gibe to patient
Tested positive for covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid 19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (abnormal) Positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Spontaneous miscarriage with no previous history of miscarriages.; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 25-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ewo198) via an unspecified route of administration, administered in arm left on 06Jul2021 at 16:30 pm as dose 1, single dose for covid-19 immunization (at the age of 25-years-old). Medical history included pregnancy from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. It was reported that on 06Jul2021 the pregnant female patient received first dose of vaccine and on 18Jul2021 at 14:00 pm she had spontaneous miscarriage with no previous history of miscarriages. The mother was 4 weeks pregnant at the onset of the event. The mother was due to deliver on 28Mar2022. Patient had not received any treatment for the event. The outcome of the event was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Patient C/O itching and hives to left side of face and neck, patient's left side of face appeared red and flushed compared to right side,  Benadryl 25mg (E-Kit) administered immediately. Patient denied SOB, difficulty breathing, and denied having any other symptom except itching and hives. Patient declined need to seek medical care. Medical Director notified. Patient was observed for approximately 20 minutes, patient reported itching was subsiding, and she did not need additional observation.
74-year-old male patient of Dr. comes to ER with above complaints. Patient states he was with his family on Christmas Eve and then found out on Christmas that there were exposed to COVID-19. Patient states he started feeling sick right away according to ER records patient was tested and was positive on Christmas day however patient states he never got tested as an outpatient but knew he had COVID-19 because his family was positive. He started to feel cough and shortness of breath and had low-grade fever. He felt extremely fatigued and tired and unable to do anything. He called 911 and was brought to the ER for evaluation. In the ER patient is found to have increased inflammatory markers, bilateral COVID-19 pneumonia is been admitted for further evaluation and treatment.
This spontaneous report has been received from a healthcare provider via a field representative concerning a 56 year old female patient. The patient's medical history and drug reactions/allergies were not specified. On 19-DEC-2014 the patient was vaccinated with PNEUMOVAX23 lot # K009105, expiration date 21-JAN-2016, (dose, frequency and route was not provided). Then the patient was seen at an urgent care center on 21-DEC-2014, and was diagnosed with bronchitis. On 05-JAN-2015, the patient was seen in the office and was prescribed unspecified antibiotics and was scheduled for a chest x-ray which was not performed at the time of reporting. The outcome of bronchitis was reported as not recovered/not resolved. The causality of PNEUMOVAX23 to the event of bronchitis was not reported. Additional information has been requested.
I experienced a swollen lymph node after the first shot on 1/12/2021. It went away within a week. After the second dose 2/2/2021 the same lymph node (left side above my collar bone , became inflamed again. It never went away but decreased in size after about 10 days. ON 2/21/the lymph node increased in size , it is the size of a grape and is very painful. I am also fatigued an have a general feeling of being unwell.
Right sided facial nerve palsy that presented 13 days after vaccine (first signs on 5/31/20; vaccine given on 5/18/20).
Faint chest paint off and on. Faint pinching feeling in heart. Evening of 8/7 till morning of 8/8
pt recvd vax & devel arthralgia, swelling hands & rash on face & lips;
After having the flu shot AFLURIA QUAD PF injected at pharmacy at 12:45 PM on October 30, 2018, five hours later, my body was shaking so bad I was freezing and could not get warm, had low-grade fever 99.2. The following day I have very sore muscles, even my eyelids ache. I have never experienced the uncontrollable shaking. This was not just a chill where you would get a random tremor this was so bad I could not even hold a spoon to eat. Was weak and had no appetite until 24 hours later. I contacted the pharmacy the next day and they told me that there had been another case of this exact thing two weeks prior. I'm just wondering how many people actually call the pharmacy after they go through something like this perhaps the amount of people affected is much greater than is thought.
This spontaneous report as received from a health care worker refers to a 8 patients of unknown age and gender who in August 2013 were vaccinated with VARIVAX 0.5 ml, subcutaneous (Lot # reported as H015222, expiry date 10-AUG-2014). It was reported that the vaccine of VARIVAX were stored in temperature conditions that were not supported by it in house stability data. No adverse effects were reported. This report is linked to 1310USA000667. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) in July 2015, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated at an emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt. experienced a headache and dizziness in addition to muscle aches and pains.
Red "blotchy" rash which started on the left arm 10/7/05 and spread over the entire body in the next two days. States the rash is itching. Denies fever. Has seen his physician and is taking Benadryl.
Patient completed Moderna 2 dose series on 4/17/21.  A duplicate record was found in PA-SIIS showing he had gotten a Pfizer first dose on 2/14/21.  Appointment was set up by long-term care supervisor who was not aware he had gotten Pfizer.  The supervisor was contacted and reported the patient had no adverse response.
Initial and follow-up information has been received through the Merck pregnancy registry through a 25 year old female who on 21-SEP-2007 was vaccinated with intramuscularly with her first dose of GARDASIL. On 25-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL. There was no concomitant medication. The patient reported that after receiving her second vaccination on 25-OCT-2007 she discovered she was "4 weeks pregnant" (LMP approximately 27-SEP-2007). It was reported by the patient that "everything was fine" and she was probably going to have a cesarean section in June. On 21-APR-2008 the patient had an appointment and "everything looked great." The baby's weight was "fine" and her fungal height was normal. "A few weeks ago" the patient experienced appendicitis and was hospitalized in order to have her appendix removed. The patient did not think the appendicitis was related to the vaccine. The patient recovered and it was reported that the patient and the baby were doing fine. No further information was provided. Additional information has been requested.
The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.
Approximately 20 minutes after receiving the COVID vaccine my face became numb. The numbness gradually increased until I could not feel the right side. Numbness lasted approximately 4 hours. My eye also began to twitch as well. The eye twitching is still an issue.
On December 29, 2021 we were about to have dinner and on the way to the table she stopped and she was holding between her left temple and her ear and cried that it hurt badly.  Then she began to twist her words, "I'm going to put the plate on the park."  She realized that she was not making since.  It appeared like stroke symptoms.  I continued to observe her further as she tried to talk more.  She sat down and began to eat.  She was unable to swallow and was complaining that her head hurt.  She was afraid to take Tylenol.  She tried to drink water but was unable to swallow.  An ambulance was called.  When EMTs arrived she was in the bathroom.  They checked her out.  Her mouth was drooped to the side.  Blood pressure was fine.  She was able to walk with EMTs to the ambulance.  Her vitals were ok but in the ambulance she was clear headed and her mouth was no longer drooping on one side.  The entire episode lasted about 15-20 minutes.  She got a shot for her headache while in the ER.  The second episode happened January 13, 2022.  She had the same symptoms but not as sharp headache pain.  She was more cooperative this time.  Her speech this time was "off".  She said "My tongue feels heavy.".  The EMTs arrived and vitals were fine.  She remained calm.  She said, "I don't feel like I can breathe right."  EMTs couldn't see an allergic reaction.  Her mouth did get twisted.  She was still able to talk this time, unlkie the first episode.  This time is was short , but the headache last for hours.  She did go to the ER again. She has not had an episode since January, but she still has the sharp headache pain.
Within 10 minutes of injection vasovagal syncope occurred in vehicle while parked in observation area. Due to being in seat was not able to prevent syncope and nurses had to treat for 15 minutes until symptoms subsided. Blood pressure was monitored and dropped to 50/20. Finger pulse oximeter would not register. Nurses provided ice packs, alcohol wipes for smelling, and water. Unable to lay flat and extend legs so episode lasted longer than expected.
Information has been received from a certified medical assistant concerning a 61 year old female who on 14-AUG-2009 was subcutaneously vaccinated with a dose of VARIVAX (Merck) (lot number 664698/0723Y) instead of ZOSTAVAX (Merck). It was reported this was human error and not a product quality complaint. No adverse effect reported. The patient did not seek any medical attention. Additional information has been requested.