chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection; This is a spontaneous report received from contactable physician.  A 11 year-old female patient (not pregnant) received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN, administration date 02Dec2021 (Lot number: unknown) at the age of 11 years as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: COVID-19 vaccine (DOSE 1; Lot number: unknown; (manufacturer unknown)), for COVID-19 immunisation.  The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection". The event "Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient had no known drug allergies. It was unknown whether, the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse refers to a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), Idiopathic thrombocytopenic purpura (ITP), sarcoidosis, drug allergy to aspirin, nonsteroidal anti-inflammatory drugs, penicillin, sulfa drugs, montelukast and nitrofurantoin and allergy to latex (specific allergic reactions were unknown). The patient was on many concomitant medications. On 01-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 dose not reported, lot# H013847, expiration date: 15-MAR-2014, intramuscularly. On 01-JUL-2013, in the evening, the patient developed redness and pain at the injection site, with swelling in the entire arm beyond the injection site, in addition it was so painful she could not lift her arm for 36 hours. Patient sought medical attention by calling the office. The outcome of adverse events was reported as recovered on an unknown date. The patient was treated with TYLENOL. No lab diagnostic studies were performed. The relatedness between PNEUMOVAX23 and adverse events was not reported. The same reporter and same mult-dose vial of PNEUMOVAX23 dose linked case: 1307USA011552. Additional information has been requested.
I developed Bell's palsy on the morning of 11/10/09.  It began with loss of taste and right sided facial paralysis.  Treatment included: oral prednisone (60 mg QD x 2 days, 40 mg QD x 2 days, 20 mg QD x 2 days) and Valtrex 1 g TID x 7 days.  Symptoms are ongoing at the time of this submission. 11/19/2009 Spoke with MD/reporter who self diagnosed and treated.  Did not seek other medical attention.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9, lot # K011562, expiry date 08-APR-2017, (dose, frequency and route of administration not reported). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. This is one of three reports received from the same reporter. Aditional information has been requested.
Swelling of glands and under tongue after an hour. Progressively more swollen until ER visit 9/25 at 3 AM. Given prednisone and BENADRYL for suspected allergic reaction. Dentist apt at 11:00 9/25 determined infection under bottom front teeth and referral to endodontist. Start amoxicillin. 9/26 emergency root canal by Dr. for immense swelling and pain, unable to set apt with endo quick enough to wait. 9/28 emergency root canal number two along with draining of infected tissue under tongue. Prescription changed to AUGMENTIN and methylprednisolone pack. 10/2 return trip to dentist with continued tissue inflammation under tongue and left side glands. Possible third root canal.
Information has been received from a healthcare worker via field representative referring to a patient of unknown age and gender. The patient was vaccinated with her first, second and third doses of GARDASIL (route, lot#, dose were unknown) on 12-AUG-2013, 18-SEP-2013 and 04-DEC-2013 (inappropriate schedule of drug administration), respectively. No adverse effect was reported. Additional information has been requested.
Moderna vaccine was administered at 7 hours past the recommended 12-hr BUD after first puncture. Bottle was kept at room temperature for a total of 20 hrs. Pt reported no significant symptoms the following day after administration, only some lightheadedness the night prior.
Headache, nausea and vomiting and diarrhea, right arm swollen with red rash. Treated with antibiotic IM and pain pills for headache on 11/17/00. On 11/20/00, "back to normal" per pt.
59 year old patient received high dose influenza vaccine indicated for 65 years old and older, no adverse side effects reported at time of report
had swelling lump on inject site & reddened area; vax recvd 4DEC91; seen in ER 6JUN92; had small hardened area under skin @ inject site-size of very small pea (both legs);
61 yo man with HLD and a family history of premature CAD, who recently underwent a total knee replacement for osteoarthritis, and has been experiencing exertional chest pain with rehab.  He was sent to the ED by his PCP, where he ruled in for an NSTEMI.  An Echo demonstrated and LVEF of 40-45% and both anterior and apical hypokinesis.  He underwent cardiac catheterization today and was found to have MV-CAD.  An IABP was placed and he was referred for CABG.  He is now symptoms free and stable hemodynamically.
Very tired, uncontrollable shivering,  fever (up to 101.4 degrees), mild headache, stomach pain, treated with ibuprofen 200 mg every 4 - 6 hours. Symptoms mostly gone 30 hours after injection.
Client reports received 1st Moderna dose at pharmacy and within minutes began feeling dizzy, fast heart rated and high blood pressure. Per client was kept 40 mins in observation and left home. Client reported that same night symptoms returned and went to urgent care. Per client EKG was normal and was kept 3hrs until blood pressure stabilized.
pt. recvd dose M-M-R II, & exp. "mumps-like synd".
Moderna on 3/10 and 4/7. Positive on 7/28
Received inject in right arm at 10:27am, and at 10pm she started feeling tightness in left cheek bone area and then left arm starting feeling like it was falling asleep and today as of 8am she was experiencing numbness in her left side of her body from cheek down to left leg. Pt has no plans to visit a doctor, recommended to see one immediately.
Swelling of side of injection no fever. Baby became less playful decreasing appetite. Swelling and erythema was during more than 10 days. CBC was done on 3/27/04 WBC 14.5. Amoxicillin 200 mg Pr was ordered, but parents refused to give to the baby.
Information has been received from a physician concerning a 61 year old female with hypertension and hyperlipidaemia and no drug reactions or allergies who on 26-MAR-2009 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) for "diabetic". The physician did not know which arm the ZOSTAVAX (Merck) was given. There were a "few" unspecified concomitant medications. On 27-MAR-2009 the patient experienced injection site reactions such as redness and hematoma and it was getting worse. No lab tests were done. At the time of this report, the patient's symptoms persisted. Unspecified medical attention was sought via phone call. Additional information has been requested.
Patient is 17. She received her first does of the Pfizer vaccine on Saturday, April 24. She was a little tired that day, but went to store that evening.  The next Thursday (April 29), she didn't feel good. She was lightheaded in the school parking lot and threw up. She came home and rested. Later that day she was fine, we went to her brother's soccer game.  The following Wednesday (May 5) she had a late evening headache and didn't feel great. On Thursday (May 6) she again didn't feel good, tried to go to school and then we drove home. Didn't feel good all day. Shakey, didn't want to eat. She said she felt like she would on a race day, sort of that knot-in-the-stomach. She didn't throw up and was not nauseous per se. Tired, lightheaded, no appetite. We went to the doctor on Friday May 7. She was weak and shaky. They ran many tests. The only thing they could find is some slight dehydration. So we kept pushing fluids and food. They thought also there is some anxiety. Upon a follow up visit with her regular primary care provider on Tuesday May 11th, they wondered about anxiety as well. Other than sometimes on cross country race/meet days when she would have the tightness in her throat and not want to eat, she has no history of anxiety or anorexia (food issues).  During this time, she had a lot of significant events. Prom (May 8th), Advanced Placement (AP) test (May 12th) and the start of summer work (supposed to be the weekend of May 8th, but she couldn't work). Her symptoms did not decrease correspondingly with the completion of these events.   Her tiredness, fatigue, poor sleeping and lack of appetite continued off and on for two months, with very gradual improvement over time. She usually felt worse in the mornings and better in the afternoon. She missed quite a bit of school. Even now in September, she has the tightness in her throat that makes her appealing food options limited.    I am not sure if this is an adverse reaction to the vaccine, however, the onset of her symptoms was unprecedented (for her) and occurred within 5 days of receiving the vaccine, so we wanted to report it.    Note: On Item 21 below, Result or outcome of adverse event, I am choosing "Doctor or other healthcare professional office/clinic visit" and "Disability or permanent damage". The "disability or permanent damage" is a question mark, as she is better than she was in early Summer but definitely not at 100% .
Patient received 1st Pfizer dose on 1/14/21 and 2nd dose on 2/4/21. RN arrived to assisted living facility to vaccinate residents. Was given patient's vaccination card which listed Pfizer doses #1 and #2 and administered Pfizer boost dose on  that day--10/28/21. After arriving back to office and entering vaccination into IRIS immunization system, noted patient had received a Moderna vaccine on 9/13/21. Notified RNs at assisted living facility and instructed to monitor patient. Assisted living RN reported no signs/symptoms/concerns per patient on 10/28/21 at 6pm.
Very quickly developed stiffness and pain in right hand middle finger knuckle joint and finger joint.  Mild symptoms in Left hand as well.  I would describe this as arthritis in these joints.
I did not have a reaction to the vaccine. I am a nurse and was exposed to COVID-19 from a patient. On 09/03/2022, I tested positive for COVID-19 with a home test. I had a headache, cough and a fever. I had to be tested at the hospital I work at to confirm diagnosis. I did not get a prescription and I took an analgesic to help with my symptoms. While recovering from COVID-19 I developed a blood clot in my leg. My doctor put me on blood thinner for 30 days and I followed up with a vascular surgeon.
At about 15 seconds after Vaccination was administered the patient collapsed (Fainted) to the floor. Patient woke up within a few seconds without recognition of what happened. No alleged injuries.
Patient had no previous issues with vaccines in the past. Patient went to the post-vaccination chairs and about 2 minutes after giving the Moderna COVID-19 vaccine, patient's wife informed me he was not feeling well. Patient was sweating profusely, shaking, light headedness, and difficulty breathing.  Site of injection looked normal.  I brought him back to the immunizing booth, laid him down, gave him something soft to lay his head on and cover- up with.  His sweating and shaking seemed to get worse. He wanted to sit in the chair since the floor was cold.  We sat him up, gave him an ice pack, and gave him some orange juice. We called 911 and instructed EMS where to find us and the patient's symptoms. While waiting on EMS, his symptoms improved slightly. They arrived quickly and assessed the patient's blood pressure, heart rate, and blood sugar. He did not feel as if he needed to go to the hospital. I had the patient wait in the immunization booth a bit longer.  He felt better, and color came back into his face. He went home with his wife. I gave them the V-Safe info, so he can report any issues while at home.
Neck/collar bone rash (2days) took Benadryl. Progressive redness/swelling at injection site. Inflamed lymph ode in left armpit. Pain and discomfort.  Serve dizziness (2 days) missed work.
headache; chills; tired; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder. Concomitant products included cardiovascular system drugs (Heart Medication).   On 14th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 14th June 2022, less than a day after receiving Shingrix, the patient experienced chills and tiredness. On 15th June 2022, the patient experienced headache. The patient was treated with acetylsalicylic acid (Aspirin). On 15th June 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills, tiredness and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: The case was reported by the patient. He received his Shingrix dose the day before reporting. The day before reporting, he had chills and was tired. On the time of reporting, 1 day after receiving Shingrix, he had a headache that he treated with two Aspirin.  He had nothing else to report.
At a recent visit (2/1/18), I recommended the second HPV vaccine. At that time mom reported to me that for two months after HPV#1, given on 9/27/16, patient had extreme fatigue and sleepiness. She believes it started right after receiving the HPV vaccine. It self-resolved after about 2 months. Per mom, there were no other illnesses or stressors occurring at that time. They did not seek any medical evaluation during this period and the first time I became aware of this was about 18 months later, at the 2/1/18 visit.
Child woke up at 03:00 fussing (night after vaccines). Mom gave Motrin because child felt warm. About 03:15, child arched back and cried for a few seconds then he would calm down. He repeated this 3-4 X over 30 min. Child was taken to ER. Child underwent blood work-up and lumbar puncture.
Pt developed cellulitis in his right upper arm the day after receiving 4 year old vaccinations.  He was treated with antibiotics.
I was on day 5 of my period when I got the vaccine. It lasted another 15 days after the vaccine and I am still spotting.  Also the normal aches and fatigue.
Administered with the vaccine beyond the 30 day use by date; 1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022; Administered with the vaccine beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date), PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 045L21A and 006F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022 at 1:42 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022 at 1:42 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date), PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  The reporter stated that they received a Moderna COVID-19 vaccine vial on 31-Jan-2021 and it was placed it in the refrigerator on the same day (specific time unknown). The patient did not report any adverse events.  Treatment information was not provided.
Patient's mother called stating patient developed a small blister on his left thigh under bandaid following vaccination (she noticed next day).
Janssen vaccine drawn on 11/15/2021 at 12:16 pm and given to patient on 11/16/2021 at 11:05 am. Patient is aware. No side effects. Will follow-up with patient in the next couple days.
Myalgia, Fever, enlarged lymph node Narrative:  stayed at home for 2 days
still feeling under the weather today; Extreme migraine like headache; Profuse Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Extreme migraine like headache), HYPERHIDROSIS (Profuse Sweating) and MALAISE (still feeling under the weather today) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061EZ1A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced MIGRAINE (Extreme migraine like headache) and HYPERHIDROSIS (Profuse Sweating). On an unknown date, the patient experienced MALAISE (still feeling under the weather today). At the time of the report, MIGRAINE (Extreme migraine like headache) and HYPERHIDROSIS (Profuse Sweating) outcome was unknown and MALAISE (still feeling under the weather today) had not resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-375450 (Patient Link).
This spontaneous report as received from a 62 year old female patient Registered Nurse and reporting on herself. The patient's medical history included breast cancer. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX, (dose, route, lot number and exp. date not provided). Concomitant therapies included CELEXA and ATIVAN. On 14-MAY-2013, patient developed a spot, with itching, that she initially thought to be a bug bite, however the patient's arms broke out with rash and she saw physician assistant on 15-MAY-2013. The physician assistant did not believe the rash was as vaccine-related and prescribed an unspecified ointment and TAGAMET for the itching, initially. TAGAMET was ineffective and ATARAX was prescribed, for the itching. On 19-MAY-2013, patient sought medical attention in Emergency Room at hospital and was diagnosed with classic chickenpox. The patient was discharged that same day and was treated with ACYCLOVIR. The patient reported she had discoloration from the rash from an unspecified date in 2013 and itching persisted. At the time of the report the patient did not recover from classic chickenpox and discoloration from the rash. Additional information has been requested.
This spontaneous report was received from a Nurse refers to a 10 year old patient. The patient was allergic to penicillin (manufacturer unknown). On 21-APR-2014, the patient was vaccinated with VARIVAX (0.5 ml once) subcutaneous in left deltoid region. Other suspect therapies included DTAP (manufacturer unknown) (dose and frequency were not reported) and meningococcal  vaccine (unspecified) (manufacturer unknown) (vaccinated in the left deltoid) (dose and frequency were not reported). On 21-APR-2014 (also reported as within 24 hours of receiving VARIVAX the patient experienced high fevers, headaches, injection site swelling, just lying around and sleeping and spreading of swelling under the arm. It was reported that the patient temperature was 101.8F. The patient sough medical attention and was seen by primary care physician and directed to apply tea bags and ice to area and take BENADRYL. The outcome of the events was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case of 1404USA014725 AND 1404USA014726 (same reporter link). Additional information has been requested.
Per mother, pt. developed hives all over 1 hour after vaccination. No fever, no SOB, no vomiting. Pt. was seen at clinic and was given BENADRYL. Rashes resolved after 3 days.
Pt given expired dose of Hepititis B vaccine. Pt mother denies any adverse reaction symptoms. Facility administered unexpired Hepititis B vaccine to Pt with mother's consent.
Initial and follow up information has been received from a nurse concerning a 21 year old female who on 04-JUN-2007 at 4:30 pm was vaccinated intramuscularly with a first dose of Gardasil (Lot#654702/0011U). After receiving her first dose she experienced severe pain at the injection site and stiffness in her left arm and neck. The patient treated herself with an unspecified hydrocortisone topical cream. On 09-JUN-2007 the patient had recovered from the event. On an unspecified date in approximately August, 2007 the patient received her second dose of Gardasil (Lot# not reported) IM and she fainted about 30 seconds later. The patient was observed for several hours. She was treated with hydration and elevation of her feet. Her blood pressure was 80/40 mm Hg after syncope and took several hours before returning to within normal range (actual measurement not reported). Subsequently the patient recovered from the event. Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 2/16/21 Lot # 037L20A;  Moderna 3/16/21 Lot# 038M20A;  Moderna 5/20/22 Lot# 038A22A;  Moderna 10/27/22 Lot# 017H22A
Redness, swelling and heat in a circle about 2"x3" just above elbow.... pt applying cold packs every 2 hours and taking acetaminophen as needed.