chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General body pain; Injection site reaction; Hives; Headache; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No known allergies.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (General body pain), INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion). At the time of the report, PAIN (General body pain) had not resolved and INJECTION SITE REACTION (Injection site reaction), URTICARIA (Hives), HEADACHE (Headache) and FATIGUE (Exhaustion) outcome was unknown.            No relevant medical history. No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Approximately 30 hours after administration of KINRIX vaccine pt developed redness, swelling and warmth to site of injection, 10 cm x 12 cm in size at time of examination 3 days after vaccine administration.
her other arm hurts as well / pain in her arms; Has a black and blue mark; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (her other arm hurts as well / pain in her arms), VACCINATION SITE BRUISING (Has a black and blue mark) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
her arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was a little sore). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   This case was linked to MOD-2022-451573 (Patient Link).
Pt we/ a hx of allergy to treenuts and "vaccine" (anaphylaxis).  35mins post vaccination, pt c/o chest discomfort (stabing, brief), tingling in Left UE, and Left jaw ache/numbness.  BP 121/70, HR 64, RR 16, O2 Sat 99% -- > 119/65, 63, 98%.  NO rash, hives, angioedema noted.  Numbness resolved. No further complaints of discomfort, numbness, or tingling.  No further reports of abnormal symptoms.  Pt stable and released from the vaccination site w/ dad @12:53.
pt states rt arm very painful, body aches-unable to raise rt arm above head red raised area @ inj site 16cm x 14cm;
FEVER, CHILLS, FATIGUE, HEADACHE, ARM PAIN, CONGESTION, SWOLLEN & PAINFUL  LYMPH NODE UNDER RIGHT ARM.  THESE SYMPTOMS LASTED FOR SEVERAL DAYS AND WHILE NO LONGER SEVERE, CONTINUES TO BE FATIGUE AND HAVE PAIN WITH SWOLLEN LYMPH NODE.
pt was given proquad on 3/9/2020; early morning of 3/11/2020, mother called that patient has a fever and a rash; c/o itchiness; she gave him tylenol; was concern about chicken pox since he had the shot 2 days before. she was  advised to give  benadryl and will see him during office hour. he came at 9:00 a.m. at that time pt had no rash. mother showed a picture and the rash looked like hives. he was not on any respiratory distress. she was advised to continue with benadryl. 2 1/2 hours later, she called and wants the patient to be seen again since he developed the rash again. he was seen . he had the hives on  his torso, few on the forehead and ears. not having shortness of breath or any respiratory distress. he was prescribed prednisolone 15mg daily x 3 days and told to continue with benadryl. later that day, he again had the rash and the on call doctor advised her to give a second dose of the prednisolone. it calmed down a bit. it came back that evening and patient was brought to Hospital ER. pt was not in any respiratory distress, no swelling of the mouth or tongue.  he was given epinephrine and  was told that he had an anaphylaxis but not sure if it was from the vaccine or the egg. he was sent home and advised to continue with benadryl. was again seen at ER the following night,  3/13/20. was given Decadron at that visit and epipen prescription. spoke to mother on 3/14/2020 and the rash finally went away as well as the fever. patient is doing better. pt will be seen for follow up next month per mom's request
Approx 9-10 days after injection, the injection site became raised, red and itchy. The following morning an extensive rash appeared on both arms, torso, and thighs looking like a severe hives reaction. As of today, day 3 of the rash, there has been some spreading on the torso sides and back. No trouble breathing or swelling of lips, eyes or throat, just very itchy, patchy rash.
Redness, swelling the first day, then next day bright red and expanded swelling (size 5 inches wide and 2 inches high) and heat (warm area). It is also painful. Patient put ice on it, took TYLENOL and TAGAMET.
Pressure, stiffness in all fingers, and dull pain. Intermittent pain increasing in frequency and duration. Paresthesia affecting the way the patient uses her hands.
Patient admitted with pancreatitis 2 weeks after first covid vaccine. Discharged home after 2 day hospitalization for IV fluids and pain control.  ***VAERs report should have ALREADY been filed by family in August 2021. Filing additional report given that I am unable to verify if reported
This spontaneous report as received from a registered nurse refers to a 5 year old patient. On 29-JUL-2013, the patient was accidentally vaccinated with a dose of GARDASIL (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Product Lot numer issue; No Adverse Event; HBP called to Report that ROTATEQ and GARDASIL 9 were administered to patients after being improperly stored. TE case with supported outcome 02386121. HBP is not aware of patient demographics or dates of administration.  Permission to contact granted; This spontaneous report was received from a consumer refers to a 11-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2023, the patient was vaccinated with the second dose of improper storage quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # reported as W013388 with expiration date reported as 16-DEC-2024, however the reported lot # occurred non-valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), but valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration were not reported) in right deltoid, for prophylaxis (product lot number issue).   Administered dose of vaccine was exposed to the temperature excursion of 47.5 degrees Fahrenheit for 1 hour. The previous temperature excursion occurred (61.7 degrees Fahrenheit  for 35 minutes) (product storage error). No additional adverse event reported (no adverse event).  This is one of several reprts received from the same reporter. ; Sender's Comments:  US-009507513-2305USA003089:MSD
Upper respiratory congestion with cough and excess mucous. Treated with Z-pak of antibiotics and antihistamine. Lasted about 1 week
having a swollen lymph node under her jaw bone; a light sore throat; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: HF9298) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sinus issue" (ongoing), notes: all year round. Concomitant medication(s) included: BISOPROLOL /HCTZ. Vaccination history included: Covid-19 vaccine (DOSE 3, unknown manufacturer), for COVID-19 immunisation, reaction(s): "weakness"; Covid-19 vaccine (DOSE 2, unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset 09Nov2023, outcome "unknown", described as "weakness"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "having a swollen lymph node under her jaw bone"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "a light sore throat". Therapeutic measures were taken as a result of asthenia, lymphadenopathy, oropharyngeal pain. Additional information: she felt weakness right after her third dose of the vaccine but it just lasted three days. As treatment the patient started by taking B complex because when she first had the weakness, when she had it for 2 days, the pharmacist said to take a B complex, so she took that for several days and then she read that maybe she needed multivitamins other than that so she stopped taking that. So, she started taking her Geritol.
Moderna  vaccine   ( NDC  80777-0273-98 ) lot #  039D21A  + GTiN  00380777273983 was administered  after the beyond date  of 10/23/2021 .  Contacted  Manufacturer  Moderna = no need  to repeat the dose  .
Pt had vaccine administered 06/13/2023. After pt received her vaccine, her skin was remarkably raised for about 2 weeks. For the last 4 weeks, small lump is palpable when skin is pushed down/touched and is tender according to pt and mother. Pt's mother stated that they have only applied ice to it once, no further treatment was taken.
Had febrile seizure lasting at least 1 min with 5 min post-ictal phase.
Patient was administered Covid 5-11 vaccine as dose 2 in series after receving Moderna 6 mo-5 years for dose 1
Disorientation, lightheadedness, dilated pupils, slurred speech starting around 3 hours after vaccine dose. Felt like I had been heavily drinking, but I had no alcohol or drugs in my system and hadn't for several days. Lasted through when I went to bed around 10:30 p.m. (about 7 hours after vaccine dose). Felt mostly normal when I woke up the following morning (around 6 a.m.) except for eyes ached. Felt completely normal by noon the next day.
The day I received vaccine I became extremely sick, fever chills, terrible body aches lasted 24 hours. Felt better, Then a few weeks later I started to develop humming in my ears, tremendous pain in my inner ear. Ruled out every acute illness. Diagnosed with neuralgia. Now on seizure medicine, still getting work up (MRI, Pain management)
pt recv vax 18JAN97 & 25JAN97 pt exp inj site redness on rt arm, raised, (3min x 2in) site warmth & itching; pt visited LMD on 27JAN97 lt arm was beginning to turn red;
this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead; this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose numbr unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead".  Clinical course: Description of Event Outcome, I know you probably get a lot of negative feedback but I want to personally thank the people who created the Covid 19 vaccine, this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead, I want to thank everyone involved in the hours and research it took to make this possible, I am great full. I know you probably get a lot of negative feedback but I want to personally thank the people who created the Covid 19 vaccine, this past week I came down with it and if it wasn't for this company and this vaccine that I got from this company, I may have ended up in the hospital or dead, I want to thank everyone involved in the hours and research it took to make this possible, I am great full. The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
New onset seizure disorder within 24 hours. Still having seizure - MRI (borderline) and EEG (abnormal).  5/2/08 Reviewed hospital medical records of 4/3-4/5/2008.   FINAL DX: new onset seizures Records reveal patient experienced witnessed seizure while home.  Seen by PCP & had another witnessed seizure while in office w/generalized tonic-clonic activity w/postictal phase lasting approx 2 min.  Parent reported that patient had been dazed upon awakening for approx 5 days but otherwise acting normal.  Vomited night before admission.  Admitted for observation.  Peds neuro consult done & tx w/antiseizure meds.  Had a few more episodes while hospitalized. Stabilized & d/c to home w/peds neuro clinic f/u.
This spontaneous report was received from a healthcare worker refers to a unknown number of patients of unknown gender and age. The healthcare worker reported that different facilities reported excursions for M-M-R II. from 26-JUN-2013 to 29-JUN-2013 for 72 hours and doses were administered. On 28-JUL-2013 for 12 hours at 9 degree Celsius and on 03-AUG-2013 for 12 hours at 9 degree Celsius excursions occurred. These were separate lots at separate facilities. She stated that does from each were administered to patients approximately on unknown dates in 2013. Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-12-09.
Breast milk supply decreased significantly for 4 days.  6 month old baby became unconsolable for 3 days
Temp up to 104 (day of shot and for 2-3 days after), leg red and swollen(day 2), very fussy/irritable (days 1-3), insomnia (day 1), poor appetite (day 1-2), staring spells(days 3-7). Shivers (days 3-7)
61 y.o. male with unknown past medical history who presented to the ED as a prehospital stroke alert.  Reportedly he was working at somebody's house and that person was inside when they heard a thud outside and found him down on the floor unable to talk.  This occurred at 3:45 PM today [10/15/2021].  Presumably he was normal prior to that.  I can get no history from this patient as he is aphasic.  We do not know what his medical history is or what meds he is on.  Discharge Note: 61 year old admitted with aphasia > L MCA CVA s/p TNKase and mechanical thrombectomy,  independent at baseline. Pt has made substantial progress with ambulation/balance since last PT visit.  On today's visit, pt tolerated  at least 1500 feet ambulation wo/AD ( 10+ minutes of ambulation) with supervision demonstrating speed changes, start/stop, backward walking, and 360 degree turns wo/instability. Narrow based balance activities require SBA  He was able to demonstrate asscending and descending steps with R rail in step over step fashion wo/difficulty.  Only mild deficits in R heel strike and R arm swing.  Has progressed sufficiently to d/c home from mobility perspective, but would need as close to 24/7 support as possible 2/2 expressive aphasia. Rec d/c home with family support and OP PT for high level balance/gait.
Pain, redness, blister at injection site day after injection. Recurring blister at injection site, tingling sensation radiating to right hand.
Fever 100.3, chills, nausea, dizziness, headache, muscle pain, joint pain, skin hurt (like pins & needles).
Focal seizure observed by school staff during lunch. (duration: less than 1 minute)  Patient dropped his spoon and the staff noticed his eyes were "fluttering" and he "was changing colors and didn't look right".  As soon as it ended, Patient wanted to lay down.  We brought him home from school.  It has been just shy of 2 years seizure-free.
My lymph nodes were swollen extremely large. The right side which I received the shot in was much worse than the left but that side swelled as well.  I went to the doctor and she told me to follow up in 2 weeks to see if they go down. I went back to the doctor 2 weeks later and she checked them again. They felt normal at that point but we did a CT scan of the head and neck and some blood work to make sure everything is now functioning properly. When I received my second dose on 04/22/21 Lot # ER8734 the same thing happened.
Vomiting, diarrhea, dehydration, given pedialyte & infamil, child vomited again after discharge; 2 siblings immunized same day w/same antigens & lot no's w/no problems;
12 hours after injection (1/8/2021) I began running a low grade fever (99.8), experiencing a debilitating headache, had injection site tenderness as well as swelling the size of a baseball. I iced the injection site and put compression on, in case it was a hematoma from the injection. From 1/8/2021 -1/10/2021 I continued to run a low grade fever, never reaching above 100 degrees. I had full body aches and was exhausted as if a bus ran me over. The injection site swelling slowly reduced with continued ice and compression. From 1/10/2021 - 1/13/2021 I did not have a fever, however I continued to experience intermittent headaches that were as painful as several days prior. I felt chronically exhausted as well. On 1/14/2021 I began to run a low grade fever again (99.8). At this point the injection side swelling was a 6.5cm x 5cm ring of what I believe to be induration. Headache and exhaustion persisted. Friday 1/15/2021 I did not have a fever, but I began to notice that simple tasks such as walking to the kitchen were increasingly difficult. When checked, my oxygen saturation was 98 percent, but my heart rate was 115 while sitting. Saturday 1/16/2021 I began running a fever again, this time reaching 100 degrees. I developed a full body rash, red spots never raised. Again, I continued to have extreme exhaustion and headaches and tachycardia. I took some benadryl to help with the rash. Sunday 1/17/2021 the rash and fever returned, headaches and extreme exhaustion and tachycardia continued. Monday 1/18/2021 I began having a sore throat, fever and rash developed again. Headache and extreme exhaustion and tachycardia as well. Tuesday 1/19/2021 my fever elevated to 100.5, headache, exhaustion, sore throat, tachycardia. However, by Tuesday there was no longer red visible spots. My entire body still itched and felt as if there was a burning sensation, however I could not find any visible red spots to correlate with the itching and burning. Today Wednesday 01/20/2021 I have never felt worse. My entire body feels like it has been repeatedly ran over by a semi truck. My throat hurts. My head hurts. My body burns as if it's on fire. I am so incredibly tired I feel like it's an extreme sport just to get out of bed and walk to the bathroom. My fever today 01/20/2021 reached a new 101.4, I'm still tachycardic. Oxygen saturation is within normal limits. However, the induration around the injection site seems to have almost completely resolve.
Customer calling states a dose of PROQUAD was administered to a 13 year old patient by one of the nurses at her facility.; No additional adverse event reported; This spontaneous report was received from a consumer regarding a 13-year-old patient of an unknown gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis by one of the nurses at her facility (Product administered to patient of inappropriate age). No additional adverse event reported.
Pt recvd 2nd dose of vax & exp h/a, fever, nausea, severe abdo pain, dec white cell count & inc serum alkaline phosphatase;
Initial and follow up information has been received from a licensed practical nurse concerning a 26 month old female patient who on  11/08/00 was vaccinated SC in the left thigh with the first dose of Varivax. Concomitant therapy on 11/08/00 included the first dose SC in the right thigh of MMRII and the first dose of Prevnar IM in the left thigh. On 01/14/02, the patient developed chicken pox lesions that begun on her torso in the morning. The patient's day care confirmed more lesions in the afternoon that appeared to be chicken pox. No medical attention was sought. Subsequently, the patient recovered from the chicken pox lesions. No further information is available.