chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; Arm ached; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and VACCINATION SITE PAIN (Arm ached) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm ached). On 18-Feb-2021, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) and VACCINATION SITE PAIN (Arm ached) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information include Honey cough drop.   Reporter did not allow further contact
Patient called pharmacy on Thurs 6/3/21 approx. 10:15am to report adverse reaction that she believed to be a result of receiving her COVID vaccine. Patient received Janssen/J&J vaccine (207A21A 06/23/2021; L arm) at our store on Wednesday, 6/2/21. She reported 30 minutes to 1 hour prior to calling us that she started experiencing sharp stomach pain (epigastric region). She denied any history of pancreatitis and has already had her gall bladder removed. I explained that was not one of the common adverse effects from the vaccine, but that it is possible that it could be attributed to the vaccine. I recommended she contact her doctor to see if they want to bring her in and examine her to rule out anything severe that may be going on. If she cannot get in touch with the doctor and the pain becomes severe, I recommended seeking emergency medical help. The only other symptom she had mentioned experiencing was the typical arm soreness at the injection site associated with intramuscular vaccines.
This spontaneous report as received from a medical assistant refers to a 18 year old female patient. No information regarding the patient's pertinent medical history provided, patient with no drug reactions or allergies. Concomitant medications reported is medication for acne (no further information). It was reported that the patient was vaccinated with three dose series of the pediatric formulation of RECOMBIVAX lot number unknown. The patient received first dose 11-APR-1997, second dose on 13-MAY-1997 and third dose on 12-MAR-1998. On 07-NOV-2015 a hepatitis B titer was drawn and showed result of "not reactive." In addition to three dose series of the pediatric formulation of RECOMBIVAX, the patient was vaccinated with one dose of the adult formulation of RECOMBIVAX (lot J013394 exp 08/25/2016) on 29-DEC-2015 and a second dose on 05-APR-2016 (lot L029631 exp 01/14/2017). On 18-AUG-2017, hepatitis B titer was done and showed a result of a surface antigen of 1000. No further information provided.  Additional information requested.
Received COVID vaccine 2/10, the morning of 2/11 woke up with stiff neck, continue to get worse, on 2/14 neck muscles started spasming around 11am, was unable to move, had to have friend take her to the emergency room around 3 pm,. The spasms continued for 11 1/2 hrs, and stiffness gradually resolved over the next 3 days, was given muscle relaxant and ibuprofen.  She has discussed this with her PCP, he encouraged her to get 2nd vaccine.
Vaccines on March 09 and March 30. COVID symptoms began July 2, 2021. Symptoms worsened, tested positive July 12.  Admitted to hospital. from July 14 - 29 in COVID unit.
Headache; nausea; fatigue; rash near injection site; This is a spontaneous report from a non-contactable consumer. A 25-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 29Jan2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. The patient's Medical history included vitamin d deficiency from an unknown date, anaemia from an unknown date, allergies: Melons from an unknown date. The patient's Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30) taken for an unspecified indication, start and stop date were not reported. The patient previously took "BNT162B2" on 08Jan2021 at 25Years (product=COVID 19, brand=Pfizer, lot number=EL23u8, lot unknown=False, administration date=08Jan2021, administration time=03:30 PM, vaccine location=Right, dose number=1). On 29Jan2021 19:00 patient experienced headache (headache) (non-serious), nausea (nausea) (non-serious), fatigue (fatigue) (non-serious), rash near injection site (injection site rash) (non-serious). No Other vaccines in four weeks. No treatment was given for the events. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information expected
On April 2, I woke up with a slight rash on my injection arm and swollen lymph nodes.
Client states she got hives from head to toe early Thursday morning 10/31/02. She went to family physician. He gave her a shot and prescription for steroid pack. She began to feel fine on second day. Symptoms disappeared by third day.
Patient said a 2 inch rash was first noticed on 2/14/2021. It was very itchy and she called her physician.  She also noticed a lump in the area of the injection.  Patient states that it is red today, and appears to be getting worse. Her physician told her to take benadryl at night for the itching and follow up with them if it does not improve. Patient will monitor for infection as well.
Event occurred after 2nd vaccine.  Was brought in to the hospital due to shortness of breath  Multivitamin, remdisivir, tylenol  Inpatient
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 22-AUG-2015 the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot number reported as "L021608", expiration date 10-SEP-2016 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Red, large swollen area to right upper arm at site of injection began gradually in the evening of 05/01/2020. Vaccines given earlier that morning. Symptoms include swelling, itch, slight stinging, redness. No pain or immobility. No reaction to left arm. No SOB, wheezing, oral edema, or other rashes. Follow up visit with PCP at clinic today, 05/04/2020, with symptoms already improved greatly with no treatments. Still very itchy and indurated. No redness and size slightly decreased, per parent and patient. 1 dose benadryl admin in clinic and well tolerated. Remaining physical exam WNL. Advised continued OTC benadryl use every 6 hours as needed for 24-48 hours or until symptoms resolve. Staff to call parent for update on child tomorrow and parent advised to call clinic if any new concerns. Overall, very mild reaction at time of visit today.
Client arrived at 9:00 a.m. for her first dose of Moderna vaccine. Client reported that she ?was being forced into the vaccine for work,? and that she ?wasn?t good with needles.? However, she was pleasant, compliant, and cooperative with the vaccine. She reported that ?it didn?t even hurt.? Approximately five minutes following, the client reported that she was ?just going to put her head down? on the table in the recovery area. It was apparent that the client was experiencing difficulty was exhibiting seizure-like activity of rigidity, dilated pupils, and extremities extended. She wasn?t able to communicate. The client was lowered to the floor and was immediately able to state her name. 911 was called. I took the client?s blood pressure as she was supine on the floor and it measured 140/80 and she was tachycardic. The paramedics arrived and the client was able to sit in a chair. Her blood pressure returned to normal, but the paramedics reported that she was slightly orthostatic upon standing. The client declined transport to a medical facility. She was given juice and water and instructed to hydrate aggressively. She remained alert, oriented, and pleasant for the remainder of her observation period prior to her release at approximately 9:45 a.m.  Prior to discharge, the client?s blood pressure was recorded at 114/70 and her pulse was 68. The client was accompanied by her fiancée.
patient was given ActHIB after it had reached temperatures of 29C for up to 3 days in error, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290230 (same reporter).  This case involves a 4 years old female patient who received a dose (4th in series) of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ161AA, expiry date: 02-May-2021, via intramuscular route in the left thigh which had reached temperatures of 29C for up to 3 days in error on 23-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, no adverse event was reported.   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.
Patient was carried into the emergency department.  Source of history: Both parents.  9 month old female presents with seizure and fever.  The symptoms began a few minutes ago and lasted for approximately 5 minutes, the patient was then post-ictal.  No diarrhea, productive cough, vomiting, rash or recent URI.  No history of recent head trauma.  No history of previous admission.  No history of recent illness.  No recent antibiotic treatment.  The parents state the patient received several immunizations today and that she is 4 months behind with immunizations, so she received the 2 month vaccine series today.  The parents also state the patient had a fever with the last series of immunizations, but did not have any seizure activity.
Itching at and around the injection site, swelling and a little redness. Injection area feels warm but I don't have a fever.
Infant patient started having fevers on the day of DTaP vaccination (2/19/09) up to hospital admission (2/20/09). Mother reported temp of 101.9 on 2/19/09. Baby was given Tylenol PRN. On night of hospital admission (2/20/09), mother was giving patient cold bath to relieve fever. Patient started vomiting and then stopped breathing and became nonresponsive, staring off, fatigued, and cyanotic (mother states baby "turned purple".  Baby was taking to ER via ambulance where admit temperature was 100 degrees F. During stay, temperature got up to 104 degrees F and patient became nonresponsive (staring off) and sats dipped into 70s. Patient was treated with O2 mask and Acetaminophen 162 mg PR. Other treatments included D5W/0.45%NS IV fluid support, prophylactic IV Vancomycin, IV Ceftriaxone, and ibuprofen PO prn fevers alternating with APAP PR. All viral/bacterial cultures (including lumbar puncture) were negative for growth. Patient's temp at discharge on 2/21/09 afternoon was 97. Final diagnosis at discharge is "Vaccine adverse event including hypotonia and fever." 3/9/09-records received for DOS 2/20/2/21/09-DC DX:vaccine adverse event. Presented to ED with ALTE and possible LOC. Fever aftger receiving vaccines.
I am pregnant and I received a Moderna Vaccine yesterday.; This spontaneous prospective pregnancy case was reported by an other (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 30-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 30-Mar-2021, EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient would like to be a part of Moderna Pregnancy Registry concomitant product is not provided. treatment is not provided
No additional adverse effects reported.; a patient was administered improperly stored doses of ROTATEQ and PEDVAX HIB.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 17-JUL-2020, a patient was vaccinated improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (strength, dose and vaccination scheme were not reported, lot number 1660946, which has been verified to be valid, expiration date reported and validated as 10-APR-2020), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, vaccination scheme, route of administration and anatomical location were not reported, lot number S021457, which has been verified to be valid, expiration date reported and validated as 03-MAR-2022), both vaccines were administered as prophylaxis (product storage error). The administered doses of the vaccines experienced a temperature excursion of 48.7 degrees Fahrenheit (F) for 2 hours 30 minutes as recorded by data logger. There was no previous temperature excursion. No additional adverse effects were reported.
Patient was given 0.5 mL dose instead of 0.3 mL. Patient was evaluated by NP.  No harm resulted.   NP reported no further action necessary.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L005301 with an expiration date of 17-FEB-2017, lot # L023594 with an expiration date of 26-JUN-2017, lot # L026405 with an expiration date of 15-JUL-2017 and lot # L041204 with an expiration date of 20-OCT-2017 (dosage number and route of administration were not provided) after following a temperature excursion on 02-MAR-2016. Nonetheless, no adverse effects were reported. The registered nurse, stated that the vaccines had the following temperature excursion: -1.3 for a time frame of 3 hours and 21 minutes. A previous temperature excursion was reported for the aforementioned vaccine on 22-FEB-2016. Temperature excursion of -1.9C for 4  hours and 43 minutes; -4.1C for 3 hours and 21 minutes and -5.5C for 2 hours and 42 minutes. Furthermore, on 29-FEB-2016, the temperature excursion was -2.3C for 6 hours and 19 minutes and on 01-MAR-2016 of -0.7 for 4 hours and 5 minutes. No product quality issued was involved. Additional information has been requested.
Developed periorbital cellulits approximately 2 wks after HPV vaccine. Her sister also had the same reaction when she received her first HPV on 4/27/22, a year later.
I had fatigue, body aches, unclear thinking for the first 2 days.  On the third day I had a fever of 102 for 3 days, sever body aches, fatigue, unable to think clearly.   I could not follow simple verbal or written instructions.  I still have a cough, SOB, daily headache and fatigue.  It is harder to breath when I am laying down and SOB increases with activity.
Nausea, headache, Weakness, Aches and Pains, minor throat irritation, & minor nasal congestion
Vaccinated with Moderna 1/27/2021 and JNJ 3/17/2021
About 1 to 2 minutes after vaccination, patient stated she felt like something from the right arm radiated up to her head, ear, nose, throat, and cheekbone. She also stated a metal taste in her mouth, then numbness on the right side of her face. I alerted the PA next door at express care to take a look at her. About 3 to 5 minutes later, patient stated having a little trouble swallowing, then the PA called 911.
?Covid arm? large itchy circular rash that occurred almost a week after the injection.  VERY ITCHY for about a week
Patient's husband called the pharmacy and reported swelling the size of a silver dollar, along with redness, warmth, feeling of the "flu" and upset stomach. They did not elaborate when asked if they needed to go to the doctor based on their symptoms.
I experienced chills and was little tired. My left arm was itching like crazy but no rash. I also developed a lump which thankfully went away two weeks.
6x5 cm redness around injection site. 1 cm diameter area indurated, firm around injection site, area tender to touch, fever x 1 night only.
Patient left voicemail reporting she had a low grade fever and ached all over. Patient reports she just wanted to let us know. LPN called and checked on patient 09/28/18. Patient reported she also had swelling on her arm, redness in the shape of a tear drop about 2-3 days after the vaccine. Patient reports she took Benadryl and she is better now. Patient reports she might get a scar from the reaction on her arm.
Initially, upper right arm swelled.  Within 36 hours following vaccine administration, every site of bee stings received over the past 10+ years-- on the right side only --swelled or itched or both, as though I had just gotten the same sting in the same location (I am a beekeeper, so had about 10 sites on the right side).  Prior sting sites on the left side did not react. [After the first vaccine dose, these same sites had, at intervals, felt like the "pinch" of the initial sting over the 48 hours following the vaccine] Now, 48 hours post 2nd dose, most of the sites have cleared and the itch has ceased completely.
Within 5 minutes of receiving the shot - Rapid heartrate, dizziness, focus on breathing Within 10 minutes - Continually increasing heartrate, dizziness, elevated legs and people fanning me Within 15 minutes - Lying down on floor because I was certain I was going to pass out  After getting on floor, an ambulance was called. Loss of feeling in arms/legs/body and/or vibrating sensation, windpipe narrowing, difficulty breathing, blurred vision, sense of doom/impending death, loss of muscle control (could not control bowels, felt like I was going to defecate myself, began to release gas uncontrollably - could not clench or control lower muscles)
Enlarging area of redness, swelling and tenderness (3" x 4" on L arm) lasting 4 days.
Patient was scheduled to receive his second dose vaccination on 4/15. Patient arrived to clinic and received second dose on 4/11, earlier than the guidelines of 28 days. Patient stated that he lost his vaccination card and knew it was around the right time, and decided to return to the clinic. The patient did not inform the clinic of this prior to receiving the vaccine.  Dr.was notified. Patient was made aware that the guidelines recommend the second dose at 28 days, not sooner . Patient had no unusual or unexpected outcomes. Patient instructed to notify his primary physician and report any adverse outcomes to SPUH infection prevention nurse. Contact number provided
Information has been received from a physician concerning a 23 year old female who on 05-SEP-2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast)  (Lot# not provided). Subsequently for 24 hours post vaccination the patient experienced flu like symptoms and GI upset. Unspecified medical attention was sought. Subsequently, after 24 hours the patient recovered from the flu like symptoms and GI upset. Additional information has been requested.
This case was reported by a nurse practitioner and describes the occurrence of vertigo in a 43 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis.  The pt received a series of three doses of Lymerix on 05/23/00, 06/20/00 and 07/18/00.  The fourth dose of Lymerix (Lot # LY145A9) was received on 08/31/01.  This represents a schedule of 0,1,2 and 15 months, rather than the recommended schedule of 0,1 and 12 months.  ON 03/31/03 approximately 57 days after the fourth injection of Lymerix, the pt experienced vertigo and dizziness which required the pt to consult a physician.  The outcome of the events is unknown.
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-537673, MOD-2022-537748 (Patient Link).
Started having chest pains and painful skin (like sunburn) on left side chest, radiating to left shoulder blade.  Thought I might be having a heart attack.  That was ruled out.  8 days later developed the characteristic rash of shingles and was seen again and started on acyclovir and pain meds.  Am recovering now.   By the way, I reported this through MedWatch because I was unable to access VAERS through the FDA/CDC portal, so you'll get this twice.  Simply meant to add to the body of info regarding post market efficacy.  Thanks.
Moderna Covid-19 vaccine EUA Reactions began Friday April 16th with pain in my underarm followed by a small lime sized red bump around injection site that began to grow in size through the day and evening. That evening it was the size of an orange and by the next morning it was the size of a grapefruit. It was red, itchy, painful ,hard and felt hot to the touch. Random red splotches popped up in and around site. Monday April 19th, I spoke with my Doctor's office who recommended taking Benadryl and icing affected area. Symptoms began to subside within a day or two although minor splotchy redness remains.
Fever x 3 days. Cyanotic episode on day 3. ER visit. IVF.