chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal hormonal changes, such as moodiness; Menstrual cycle started 10 days early; Non-stopped menses; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle started 10 days early), HEAVY MENSTRUAL BLEEDING (Non-stopped menses) and MOOD SWINGS (Normal hormonal changes, such as moodiness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle started 10 days early) and HEAVY MENSTRUAL BLEEDING (Non-stopped menses). On an unknown date, the patient experienced MOOD SWINGS (Normal hormonal changes, such as moodiness). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle started 10 days early), HEAVY MENSTRUAL BLEEDING (Non-stopped menses) and MOOD SWINGS (Normal hormonal changes, such as moodiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 5 (booster), single (Lot number: EN6207) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing), notes: other medical history: Dermatomyositis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 06Mar2023 to 11Mar2023. Clinical course: the patient had other medication within 2 weeks. She had sore throat, stuffiness, and her chest tightness returned.  No follow-up attempts are possible. No further information is expected.
Lungs were filled with fluid; couldn't breathe; fatigue; woke up in the middle of the night; couldn't lean back; felt like her lung was on fire; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer, the patient.  This 62 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 24Jan2021 for COVID-19 vaccination. Medical history was unknown. Concomitant medication sere unknown. On an unknown date, the patient experienced severe adverse reactions after the 1st dose reported as she woke up in the middle of the night and couldn't breathe/difficulty in breathing and lasted for 4 hours, her lungs were filled with fluid and felt like her lung was on fire, couldn't lean back and had fatigue the next day. The clinical outcome of woke up in the middle of the night couldn't breathe/difficulty in breathing, lungs were filled with fluid, felt like her lung was on fire, couldn't lean back and fatigue was unknown.
Beginning in October 2012, I began to feel lethargic.  I was sleeping more than normal and had less energy.  I felt like I had a sinus cold.  As this was the beginning of cold and flu season, I decided to wait it out and not seek medical assistance at that time.  On November 2nd, 2012, I began my work trip.  I met up with a work colleague in the airport.  Upon seeing me, he immediately asked about my health.  We had just concluded a business trip in the previous months and he was surprised that I was not looking very well.  I said that I had been feeling more tired than normal, but hoped it was just the cold season.  I arrived on the third, and returned on the 9th.  I did not seek medical attention while traveling. Upon returning home, my wife noticed that my behavior had changed.  I was less energetic, less enthusiastic, weak, acting depressed, keeping quiet, and keeping to myself.  I decided it was the jet lag, but I did not get better.  In fact, I was getting worse. On December 1st, 2012, my family went out to dinner.  The meal was good, but I did not interact with them very much.  I was quiet and tired.  Upon leaving the restaurant, I had to stop three times to catch my breath while walking to the car.  I was breathing very heavily, I was very weak, my chest hurt, and I was unable to catch my breath.  I went to the emergency room. Upon arriving at the emergency room, they immediately started to pre-treat me for a heart attack.  All of the symptoms matched, and it was standard protocol.  When the cell blood count (CBC) results returned and the heart tests showed negative, they stopped the heart attack treatment and began blood transfusions.  My hemoglobin count was 5.1, normal is above 12.  My white blood cell count was 0.8 (above 5 is normal) and my platelet count was 6 (above 140 is normal).  After transfusing several units of packed red blood cells, a subsequent CBC test reported a hemoglobin level of 4.1.   The doctors reported to me that they had administered upwards of 100 tests to determine what was wrong and what had caused the symptoms.  Based on the results, I was diagnosed with severe Aplastic Anemia.
Swelling on left shoulder approx twice the normal size by 0500 the next morning 19May2010.  Itchy feeling, and moderate pain, and muscle weakness.
Experienced tightness of the throat and some difficulty breathing about half an hour to an hour after. I also experienced difficulty breathing for about a week so much so that my employer had me evaluated in the emergency room and tested for COVID-19 twice (results were negative both times). I received a saline IV for hydration, chest x-rays, and blood tests to rule out infection. My normal side effects consisted of chills, body aches, tiredness, headache, and nausea.
8JUN95 devel heat type rash on chest, shoulders & back; rash devel 8JUN95 2 hr p/swimming in lake; no improvement p/dose of DPH; 12JUN95 rash still present but has faded in color;
Fever developed the day following immunizations.  She received Pentacel, MMR, Varivax 1/7/11.  Fever to 101 on the first day.  Intermittently running temps up to 99 since then.  She has had diarrhea for the past several days, up to 5 loose watery stools per day.  Cough 1/18/11, Rash started that evening night around her face, spread to the rest of her body by 1/19/11. On exam 1/19/11 had diffuse morbilliform rash and koplik spots.  Afebrile with normal VS, otherwise normal exam.
I21.A1 TYPE 2 MI 4/18/2023 DIASTOLIC HEART FAILURE, ACUTE
My adverse event started after 2 days of my vaccine on 01/30/2022 in the morning when I woke up I felt pain in the lower right  side where the kidney is. In a scale the pain will be 2-3. It was uncomfortable. I ended up in the ER for something else. The pain subsided. I also had fever. I noticed my cataract got worse. I had a cataract surgery. I went back to work and I was having difficulty looking at the computer screen. I had extreme hypertension without reason. I had tested positive 2 times for COVID-19 infection on 05/18/2022 and 08/28/2022. My symptoms for the first time were mild but the second time I had COVID-19 symptoms were worst. I had fatigue, headache, runny nose, cough, and fever for 7 days. On 08/29/2022 I went to the ER. They didn't prescribe me any medications. They offered me infusion and tablets but I declined to take. I took over the counter medications such as TYLENOL and NYQUIL. I haven't recovered yet now I have hypertension which can't be control. I have a CT scan coming up on 02/02/2023.
Patient received Janssen (J&J) vaccine on 1/12/22 and received Moderna booster on 02/19/22. Booster shot was less than 60 days from initial J&J shot. Per patient, he had mild symptoms on 2/20/22 (temperature 99 degrees) that was the same as when he received the J&J vaccine. He feels 100% on 2/21/22 with no symptoms.
an issue with the heart; intense heat; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat). At the time of the report, CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082280:
tenderness in scalp and back of head; barely able to move my leg; diagnosed with muscle spasms; soreness of arm; bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), HYPOKINESIA (barely able to move my leg), MUSCLE SPASMS (diagnosed with muscle spasms), PAIN OF SKIN (tenderness in scalp and back of head) and PAIN IN EXTREMITY (soreness of arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, CELECOXIB (CELEXA [CELECOXIB]), MELOXICAM, TRAMADOL and VITAMINS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CONTUSION (bruising) and PAIN IN EXTREMITY (soreness of arm). On 18-Feb-2021, the patient experienced HYPOKINESIA (barely able to move my leg) and MUSCLE SPASMS (diagnosed with muscle spasms). On 02-Mar-2021, the patient experienced PAIN OF SKIN (tenderness in scalp and back of head). The patient was treated with METHOCARBAMOL (ROBAXIN) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (bruising), HYPOKINESIA (barely able to move my leg), MUSCLE SPASMS (diagnosed with muscle spasms), PAIN OF SKIN (tenderness in scalp and back of head) and PAIN IN EXTREMITY (soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event included muscle relaxers.
On 10/15/2021     Felt bad,   profuse sweating, called his doctor and was referred to Hospital ER. Admitted to hospital 10/16/2021
This spontaneous report as received from nurse via a company representative refers to a 16 year old female patient. On 15-JUN-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N019104, expiration date 03-FEB-2020, intramuscular in arm for prophylaxis. On the same day, the patient experienced dizziness and passing out. She was treated and recovered in the physician's office on the same day. Causality assessment was not provided.
fainting; headache; muscle pain; pain at the injection site; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 10Sep2021, this case now contains serious adverse reaction. Information processed together.    This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.     A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on 25Aug2021 at 14:20 (at the age of 13-years-old) at dose 2, single for COVID-19 immunization. Medical history included being insulin-resistant and circumcision on 2014 (7 years from this report). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular 04Aug2021 (at the age of 13-years-old) at dose 1, single for COVID-19 immunization. On 25Aug2021 15:00, the patient experienced headache and fainting; muscle pain and pain at the injection site on unspecified date in Aug2021. The patient's mother wanted to know if there were any complications since patient is insulin resistant and if the condition made the effects worse. She mentioned that she made the people aware of their conditions before getting the vaccine. The mother was worried with the patient having headache and fainting for seconds about 2-3 times after vaccine and don't want to go a hospital for contagious about COVID-19. Therapeutic measures were taken as a result of headache and fainting and included treatment with TYLENOL. The outcome of the events fainting and headache was not recovered; all other events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116680 same reporter, suspect drug and events; different patient
Upset stomach -liquid poops from 1pm until about 8pm, several episodes (5).
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (had history of chicken pox). Previously administered products included Flu vaccine with an associated reaction of headache (Received flu vaccine in the past refer case US2018GSK185831). On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 21st March 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and headache. On 24th March 2018, the patient experienced itchy rash, sunburn-like rash and heat rash. On an unknown date, the patient experienced bedridden and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain, headache, bedridden and itchy rash were recovered/resolved and the outcome of the sunburn-like rash, heat rash and incomplete course of vaccination were unknown. It was unknown if the reporter considered the influenza-like symptoms, general body pain, headache, bedridden, itchy rash, sunburn-like rash and heat rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on 20th March 2018. The patient has not yet received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination and was not sure if she would be getting the 2nd dose. The patient stated that the day after she received the 1st dose of SHINGRIX, she experienced, flu-like symptoms, headache, body aches and felt like a truck had hit her. The patient stated that she was bedridden for 1 day and then the symptoms resolved a few days later. The patient stated that on 24th March 2018, she developed a hot itchy rash that was on her upper left arm a few inches below the injection site, the size of the rash was larger than her hand, it was bright red, felt hot to the touch, and felt like a severe sunburn. The patient stated that the rash lasted for approximately 1 week. The patient stated that she had received flu vaccines (unknown manufacturer) in the past and after receiving them, she has experienced body soreness and headache (Refer case US2018GSK185831) the patient stated that the soreness that she felt after the flu vaccine was different than the body aches that she experienced following the SHINGRIX vaccine. The patient stated that she had not received a flu vaccine in at least 5 or 6 years. The patient did not have any additional details regarding the adverse reactions that she experienced after receiving the flu vaccines.
child's arm "has a huge red, swollen area at the site of the vaccine.  No swelling of the lips, tongue, no difficulty breathing".  This is child's "second reaction and slightly larger than last time".  Benadryl TID ordered x48 hrs by clinician after reaction reviewed with mom.
Injection site reaction, redness, swelling of soft tissue, warmth at injection site. Symptoms for >1 month. Advised ice, time, observation.
Nine days after receiving the vaccine, I got a rash on my left upper arm at the site of the shot. It grew steadily bigger and itched and went away in about week. I used hydorcortizone cream to relieve the itching.
Psoriasis; Period; Premenstrual syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSORIASIS (Psoriasis), PREMENSTRUAL SYNDROME (Premenstrual syndrome) and MENSTRUATION NORMAL (Period) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced PREMENSTRUAL SYNDROME (Premenstrual syndrome). On an unknown date, the patient experienced PSORIASIS (Psoriasis) and MENSTRUATION NORMAL (Period). At the time of the report, PSORIASIS (Psoriasis), PREMENSTRUAL SYNDROME (Premenstrual syndrome) and MENSTRUATION NORMAL (Period) outcome was unknown. Unknown          No concomitant medication details were provided. No treatment medication details were provided.
Patient contracted COVID-19 infection that lead to hospitalization after receiving Pfizer vaccine.  Patient received at least one dose, unknown if she completed series and received booster doses.
Initial report received on 10 January 2008 from a health care professional. A 39-year-old male patient, who had no concurrent illness, pre-existing medical conditions, or use of other medications had received a dose of FLUZONE SV 2007-2008 (lot number U2464AA) on 18 October 2007. The route and site of administration was not provided. The following day, after receiving the FLUZONE vaccine. the patient experienced a "staph infection." No relevant diagnostic tests, or laboratory data were performed to confirm the diagnosis of "staph infection". At the time of this report, the patient had recovered. No other relevant medically significant information was provided. Follow-up information was received 08 August 2008 from a health care professional. The reporter reviewed the case information and had no new relevant medically significant information to provide at the time of the report. The reporter for this case is the same for case 2007-03565, which is a case for a 55-year-old female who developed a "staph infection" after administration of the FLUZONE SV2007-2008 on 16 October 2007.
Received immunization 8/30 9:30 am, swelling noted. Occurred 8/31 9 AM with redness. Lost arm (left) hurt. Pain now gone. 15cm long x 50 % around left arm.
I didn't make the connection at first, but I had some heart palpitations and a general uneasy feeling in my chest. It was similar to the feeling I've had with other viral infections. at first, I thought it might be stress or anxiety, but it didn't resolve when I used my relaxation techniques. The palpitations were only a day or two, but the uneasy feeling in my chest lasted about a week. I received my first two doses of the Pfizer vaccine in February 2021 and a booster dose in September 2021. I have never tested positive for Covid-19.
09/07/2021 started having episodes of fatigue and leg weakness. Couldn?t see Dr because Covid cases were high. Wife and family had Covid. Episodes off and on then progressed to muscle loss and weakness over the next several weeks. Saw family Dr on 11/16/2021, had labs done all were normal. Symptoms continue to progress made appointment with neurologist, couldn?t get an appointment until 12/23/2021. Symptoms severe, after labs, MRI and EMG diagnosed with Myesthenia Gravis.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CONCERTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative on multiple tests multiple days in a row before the rebound began; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks was Concerta. The patient received Paxlovid (Antiviral, Lot number: GA3581) from 24May2022 to 30May2022 for COVID 19 treatment. Covid-19 rebound after completing Paxlovid treatment. The patient tested negative on multiple tests multiple days in a row before the rebound began.
Fever 102 x 2 days, sore throat, hard to swallow, tingling sensation in hands, feet, & knees; whole body seemed numb;
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAY-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 0471AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Patient here to receive Booster after J&J 1st shot 6 mos. ago. Requested Moderna for 2nd shot. Patient given .5ml Moderna instead of .25ml. Due to miscommunication. No adverse reactions observed.