chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluish; Felt achy; Heart palpitations/I still have palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations/I still have palpitations), INFLUENZA (Fluish) and MYALGIA (Felt achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa, iodine, flagyl, Macrobid, Levaquin, dalandid, cipro, percocet) and Fibromyalgia since 1990. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, PRAVASTATIN for Cholesterol, AMITRIPTYLINE for Fibromyalgia, VITAMIN D NOS for Palpitations, BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PALPITATIONS (Heart palpitations/I still have palpitations). On an unknown date, the patient experienced INFLUENZA (Fluish) and MYALGIA (Felt achy). The patient was treated with METOPROLOL TARTRATE for Palpitations, at a dose of 12.5 mg. At the time of the report, PALPITATIONS (Heart palpitations/I still have palpitations) was resolving and INFLUENZA (Fluish) and MYALGIA (Felt achy) outcome was unknown.            This case was linked to MOD21-091293 (E2B Linked Report). This case was linked to MOD-2021-138697 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up information received on 19-JUN-2021. Added patient medical history and concomitant medications.; Sender's Comments:  MOD21-091293:Husband's Case
Breakthrough case admission after 3 vaccines: Moderna 2/24/21 Lot# 024M20A; Moderna 3/24/21 Lot# 007B21A; Moderna 1/23/21 Lot# 012H21B.
Patient's anxiety increased post-immunization. She stated she could feel herself getting faint and trying to take deep breaths to try to calm herself down. Her eyes rolled back, she started to moan/slur speech and then displayed seizure-like convulsions while slumping over. Pharmacist caught her head before it hit table in room and called 911. Prior to paramedics arriving patient awoke and asked what happened and if she fainted. She did not have any issues with speech,  swallowing, was lucid and stated she felt fine.
Swelling of face/tongue, red rash to neck, face, axillae, and chest, maculopapular rash to chest, legs, and groin.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M046134 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA014122: US-009507513-1703USA014120: US-009507513-1703USA014121:
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sore arm for 3-4 days; felt puny that lingered for 4-5 days; Nausea that lingered for 4-5 days; Chills that lingered for 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days). At the time of the report, PAIN IN EXTREMITY (Sore arm for 3-4 days), FATIGUE (felt puny that lingered for 4-5 days), NAUSEA (Nausea that lingered for 4-5 days) and CHILLS (Chills that lingered for 4-5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No relevant concomitant medications were reported. No treatment information was provided.
2nd dose:  Pt  c/o "numbness down my arm and it feels cold down to my hand" left arm, "intermittent numbness".  Tingling felt like crawling ants on arm.  "more numb in my last two fingers", "discomfort in nape of neck, lightheadedness, and tunnel vision". Patient given 8oz of fluids, PO.  BP: 180/105.  No medications administered.  Transported to ED.   Recovered night of 1/16/21.
On May 23rd I was taking out the trash and I did not feel right.  I went to lay down and my chest, throat and head started to feel tight.  I called the ambulance and went the ER.  In the ambulance they had to give me medicine to start my organs again, they told me that they were getting ready to shut down.  They took me to the ER to stabilize me.  I was going to the bathroom and I had another attack and they had to give me other medicine to start my organs again.  They admitted me to the ICU, which I was three for 4 days.  At first, they did not know what was going on.  Then they transferred me to another Hospital for a Cardiac Ablation.  I went home shortly after that and then shortly after being home I started to have the symptoms again.  My resting heart rate was over 200 bpm. At first, I thought it was fluttering but then the symptoms started to get worse.  I went back to the ER and they admitted me over night for observation.  They determined that I had another part of my heart not working properly which now they are going to do another cardiac ablation. My doctor as of right now is monitoring me.
Small red patch at site of injection. Also it was hot and hard. Place cold compress on site. This morning on arising right arm was numb.
strong headache; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL3302; Expiration date: May2021) via unspecified route of administration in the left arm on 02Feb2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. Patient had not prior vaccinations within 4 weeks. The reporter stated that their company was asking for reporting of any possibility of reaction after vaccination. On 04Feb2021, about 48 hours after the first dose, the patient experienced strong headache which was resolved in 48 hours. The adverse event did not result in an emergency room or physician office visit. The outcome of the event was recovered on 06Feb2021. It was reported that the patient was very irritated that he has been on hold for 93 minutes.   No follow-up attempts are possible. No further information is expected.
10/28/02 -Td given right deltoid IM, The next day arm with swelling, redness, skin hot to touch, Blisters appeared 3 days later, Clinic physician looked at site 11/05/02 Advised Benadryl 3 x day & Tylenol
Patient has had two seizures since her H1N1 shot that her neurologist attributes to the vaccine.  Her siezures weer 11/20/2009 and 11/28/2009.
On 2-15-15 within 3-4 hours of vaccine pain to leg at night temp 99-100. On 2-16-15 temp 102 in AM. Leg pain worse, refused to bear wt screamed when thigh touched at injection site. After last visit pt received PNEUMOVAX in (L) thigh.
The patient is a 75-year-old gentleman who presented the hospital complaints shortness of breath and cough.  On presentation the patient was found to have acute respiratory failure and sepsis secondary to COVID-19.  The patient was placed on supplementary oxygen and started steroids.  The patient ended up recovering faster than anticipated and was quickly able to be weaned from oxygen.  The day after admission the patient was noted be on room air at rest.  With ambulation the patient had saturations at lowest of 93%.  He reported feeling significantly improved.  We discussed symptoms to monitor at home.  Inflammatory markers were only mildly elevated during patient's admission.  The patient was felt stable for discharge home.  The patient reports he has a pulse oximetry monitor to continue watching his saturations at home.  Questions have been answered to patient's satisfaction and he is being discharged in stable condition.
Immediately following the injection, patient experienced soreness at the injection sight, then feeling faint, dizzy and slightly nauseated.  He then had tingling in his left hand (injection was in left arm) and then tingling in right hand, and both arms "felt heavy."  After the tingling subsided somewhat, his legs and then whole body started shaking.  He was given some water to drink.  Symptoms were significantly improved after 20-30 minutes, and we left the pharmacy area where we had been seated during this time, and went home.
Initial information received on 22-Mar-2019 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves a 6 months old female patient who received vaccine PENTACEL (lot U6138AA and expiry date 07-Jul-2020) via intramuscular route with DTaP-IPV portion given separately from the HIB component on 22-Mar-2019.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included Hepatitis B, pneumococcal conjugate vaccine and rotavirus vaccine. It was a case of actual medication error due to inappropriate reconstitution technique. Patient did not had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Irregular vaginal bleeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Irregular vaginal bleeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (Irregular vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (Irregular vaginal bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
pt devel temp 101; 8-10 lesions; small, some w/blisters; ear infection
Exactly three weeks after my vaccine, I experienced a food impaction in my throat,  also started having a lot of acid reflux.  I was woken up with a severe heartburn attack in April.  I got in to see my GI in June and was  able to get an endoscopy.  The results showed I had Eosinophilic esophagitis, EOE.  My Eosinophilic number was 25.  I was put on an elimination diet, no dairy, eggs, nuts, seafood, along with already being gluten free.  I was also sent to an allergist and am now doing three shots twice weekly.  I have never, ever, had an issue with these foods before or had swallowing issues.
Patient reported to pharmacy to receive his 2nd dose of the Moderna covid vaccine. Patient only received a half dose, booster dose, instead of a full dose. We noticed the error at the end of the day, and we called patient on 11/16/2021 to inform him of the error and had the patient come into the pharmacy to receive the full dose to replace the mistaken booster dose.
Productive cough; Swollen lymph nodes on neck; Severe body aches; Chills; Minor headache; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: Ek5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt has hx of recent flu shot 3 weeks ago. Has erythema and edema to right deltoid around injection site. Pt has hx of flu shot every year x 8 without difficulty or irritation at injection site. Pt states shot did not hurt at time of vaccination. No abnormal pain at time of injection. Pt states she noted each day since injection mild itching, mild fever, increasing daily around injection site.
my eyesight began to change dramatically. I developed "holes" in my sight; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 13Apr2021 11:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown, Anatomical location: Right arm, Administration time: 10:00 AM), administration date: 23Mar2021, when the patient was 55 years old, for covid-19 immunization. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 14Apr2021 07:00, outcome "not recovered", described as "my eyesight began to change dramatically. I developed "holes" in my sight". Therapeutic measures were not taken as a result of visual impairment.  Additional information: After the second dose, her eyesight began to change dramatically. She developed "holes" in her sight that have made it almost impossible to read a computer and perform other tasks. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First vaccine 8/5/21:  I have an IUD and have not had a period requiring tampons in about 6 years. 8/7/21 had experienced extreme cramping in my lower abdomen. In the morning of 8/8/21 I had bright red heavy menstruation blood; something I have not had in over 6 years. The bleeding continued for about 2 weeks. I also had weird large dark red/purple blood clots coming out.   After about 2 weeks, the bleeding decreased, however, I still have weird discharge, clots, and spotting. After I received the second Pfizer vaccine on 8/27/21, the bleeding turned bright red again and increased for a few days.  Second vaccine 8/27/21 in the AM: On 8/28/21 I woke up covered in full body hives that were itchy, welted patches. Some with red around them. My right arm, which is the one I had the vaccine on, had different type of hives. My right arm was covered with flat red itchy hives that also burned.   I continued to have the full body hives until 8/31/21. Now I get random welted hive patches.
Technician (licensed to vaccinate) administered vaccine to patient near pharmacist.  20 seconds or so after administration, patient stated felt dizzy and immediately became unresponsive and head dropped to chest.  Technician stated he then lifted the patients head because he heard a "snoring" sound indicating airway may be constricted due to positioning.  Technician stated the patient's body twitched and became ridged, throwing her belongings. He called pharmacist (myself) for assistance. I immediately checked for breathing and pulse, both of which were evident.  I observed pt vitals for about 20 seconds before the pt opened her eyes and was responsive and able to talk to me.  Blood pressure was 120/69.  Pt remained in the pharmacy waiting area for 30 minutes after.  Patient said that in the past she has nearly passed out from piercings she has had, but has never fainted before and has no history of seizures.
Became sick twice in two weeks since receiving the vaccine; both times a severe fatigue, chills, muscle weakness, and body ache.
Sore throat on days 1 and 2, runny nose and congestion days 2-5.
continued achiness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix the patient experienced continued achiness, tiredness The patient asked how long do shingles vaccine side effects last. For tolerance after 2nd dose of Shingrix, refer case US2020AMR103218.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR103218:Same Patient
GENERALIZED ADENOPATHY, ANGIONEUROTIC EDEMA TO EYES, MOUTH, GENERALIZED FACE.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took other medications in 2 weeks. The patient was treated with Paxlovid for COVD-19 from 14Jun2022 to 18Jun2022. Rebound COVID-19 infection following Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient presented to clinic to receive 2nd dose of Pfizer COVID vaccine. NP SD cleaned arm with alcohol swab, grabbed a syringe and inserted needle in arm, attempted to push but no vaccine in clean, sterile syringe/needle. Less than 0.1mL air bolus administered. Provider then had to administer a second needle this time with the vaccine.
Donor states in evening post shot he has abdominal cramping started approximately 0000Hrs resolved approximately 0800 in Am. Donor denies any other symptoms.  Denies any fever, chills, (-) NVD. Donor did not seek any medical attention.
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised and he got re-vaccinated with Pfizer#4  on 5-6-2022. Patient did not report any adverse events.
Loud ringing in ears.; Feeling cold; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 19:00 (at the age of 49-years old) as a single dose for COVID-19 immunisation. Medical history included colitis, penicillin allergy and gurds. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 at 19:30, the patient experienced loud ringing in ears and was feeling cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in ears and feeling cold was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.