chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on arms, back and legs/ rash was itchy; rash looks and feels like chickenpox/spots look like pimples; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix. On 7th September 2019, 25 days after receiving Shingrix, the patient experienced itchy rash and varicella-like rash. On an unknown date, the outcome of the itchy rash and varicella-like rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient.  The patient received Shingrix in her left arm.  The patient stated that on Saturday, she developed a rash on her arms, back and legs. The rash was itchy and looked and felt like chickenpox. She also stated that, the spots looked like pimples. The patient consented to follow up and provide details of her physician. The patient did not provide any additional information.
17 yo male received 1st dose Moderna COVID 19 vaccine. After error was discovered a second dose was administered per CDC recommendation
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 02/16/2021 and 03/09/2021. They presented to emergency department on 08/16/2021 via ambulance, after being sent over from an urgent care facility with primary complaints of elevated white count and shortness of breath. They were admitted to hospital 08/16/2021 and tested positive for COVID-19 upon admission (on 08/16/2021). They experienced complications of pneumonia, respiratory failure, sepsis, and epileptiform activity on EEG. They remained hospitalized until their death on 09/11/2021.
For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (For the original Moderna Covid-19 vaccine, do you have  a day, or two, after the beyond use date to use it, still).    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
Tooth sensitivity  Mouth sores - gums, palate, lips, tongue swollen with sores.   On and off since vaccination. Lasts several days then dissipates.   3 episodes so far - lasting 2 days.   Dental sensitivity has been constant.   I have been treating with mouthwashes with some relief.
This spontaneous report as received from a healthcare worker refers to approximately 4 year old male patient. On 18-FEB-2013 the patient was vaccinated with MMR II (dosage, lot # and expiry unspecified) dose 1 for vaccination. The healthcare worker reported that on 31-JAN-2014, the patient was administered an expired dose of MMR II (lot 0232AE expiry date 26-JAN-2014). No adverse event reported. No other information was reported. Additional information is not expected.
Fainted with seizure like movements in body.  Blood pressure went extremely low and took about 1 hour to come back up.
Red at the injection site and hot to the touch .. Started spreading down my hard and getting bigger.. My left Lymph Node in arm pit  was swollen and tender Mild fever
Positive COVID test; Congestion; Cough; Nasal drip; Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), COVID-19 (Positive COVID test), NASAL CONGESTION (Congestion), COUGH (Cough) and RHINORRHOEA (Nasal drip) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Congestion), COUGH (Cough) and RHINORRHOEA (Nasal drip). On 27-Mar-2021, the patient experienced COVID-19 (Positive COVID test). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN [CHLORPHENAMINE MALEATE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Scratchy throat), COVID-19 (Positive COVID test), NASAL CONGESTION (Congestion), COUGH (Cough) and RHINORRHOEA (Nasal drip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Her arm became very red, big, hot and really itchy for 4 days after receiving the shot.; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot.; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot/itchiness; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown , Manufacturer unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2023, outcome "recovered" (2023), described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 2023, outcome "recovered" (2023) and all described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot."; PRURITUS (non-serious) with onset 2023, outcome "recovered" (2023), described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot/itchiness".  Additinal information: Patient had 2023-2024 vaccine on 18Oct2023. Her arm became very red, big, hot and really itchy for 4 days after receiving the shot. It was annoying for 4 days. It was reported that the itchiness felt like the worst mosquito bite. She read that it was 'COVID arm' and also read that it was rare. She didnt experienced this with the other COVID vaccines (unclear mfg for prior COVID vaccines).   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Within 24 hr of vax, several pt devel lymphadenopathy & inject site rxn of redness, soreness, itching. Reporter is unable to identify any of these pts.
I have a lymph node under my same armpit that I had the shot in; its sore under my arm pit; it's sore under my arm pit; I feel yucky all week; I haven't feel particularly well all week; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "I have a lymph node under my same armpit that I had the shot in; its sore under my arm pit"; AXILLARY PAIN (non-serious), outcome "unknown", described as "it's sore under my arm pit"; MALAISE (non-serious), outcome "unknown", described as "I feel yucky all week; I haven't feel particularly well all week".  Additional information: The patient stated, "I had the Prevnar 20 Vaccine on Tuesday and today I have a lymph node under my same armpit that I had the shot in and I didn't know is that was a reaction to the injection or something totally different?" Consumer stated, "I feel yucky all week not particular but I haven't feel particularly well all week put it in that way instead of yucky. The injection site is no longer sore, it's sore under my arm pit where the node is."  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
On 11/18/2022  had a Transesophageal Echocardiogram (TEE) test and after the procedure they found that that my heart rate and oxygen levels were really low. Was supposed to be an Outpatient procedure, but they admitted me because my levels were too low. Was admitted to the hospital for 3 days. About a week after getting home from the hospital, started feeling cold symptoms and took a home COVID-19 test and was positive. Decided to rest and quarantined.
1.  Flu like symptoms evolving into bacterial upper respiratory infection, bedridden for 2 days. 2.  Weeks to follow extreme lethargy, numbness blood tests confirmed Guillain Barre syndrome.
This case was reported by a physician and described the occurrence of fever in a patient who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis.  On 06/10/2003 the patient received an injection of Pediarix.  Later that day, at an unspecified time post-immunization, the patient experienced a "high fever."  The outcome of the event is unknown.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 23-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis.  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Dizzy and lightheaded and some tachycardia approximately 5 min. after getting vaccine. Continued off and on about 3 hrs. Went away and returned in the evening on 11/3/09, Day of shot.
Swelling and tenderness on right check. Feels like I got punched on my right cheek.
On 11/18/2022, after receiving my vaccine, I began feeling run down. I took some TYLENOL that night. The next day, I was feeling lethargic and had body aches. That lasted a few days before the symptoms went away on their own. However, around 01/13/2023, I started having bad headaches again. Prior to 01/13/2023, I could feel some heaviness in my head, but I didn't have any pain. I have gotten headaches like this after every dose of a COVID-19 vaccine before this one as well. I also experienced an optical migraine while I had COVID-19. I had to call an ambulance because I lost vision. Since 01/13/2023, I have been experiencing floaters and headaches regularly. I have not yet seen a doctor for this specific round of headaches. I've been treating myself with ADVIL and TYLENOL.
JAUNDICE; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced jaundice, and vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jaundice and vaccine exposure via breast milk was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
8/15/01 evening--tingling in hand/limbs, numbness. Sores in mouth, lips sore, rash and lethargic for 5 days. rash all over body and in mouth. Called ECHD--given CDC #. 4-5 days later, felt better. Lost 6 pounds.
Am I outside the window to receive a second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C20A) for COVID-19 vaccination. No Medical History information was reported.    On 29-Apr-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 PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Elevated heart rate 150 range and shortness of breath at 5:15 PM day of vaccine. Sore arm next day. On 10/28/21 in the evening noticed lymph node soreness in left armpit, same arm as injection. Heart rate elevation randomly up to 140 range while resting throughout the days following injection. Fever on 10/29/21 and increased pain in lymph node.
Breakthrough of COVID-19 virus with running nose, cough, body aches. I had to take the antibody infusion on 07/15/2022.
Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.; experienced normal side effects; lessergy for 1 or 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, VITAMIN 15, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), RUBUS IDAEUS (BERRY ACTIVE RASPBERRY KETONES) and CENTRUM JR [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;TH for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 experienced HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.) (seriousness criterion hospitalization), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days). At the time of the report, HOSPITALISATION (Caller also mentions that she was hospitalized recently, and when asked she answered that for nothing related to COVID.), VACCINATION COMPLICATION (experienced normal side effects) and UNEVALUABLE EVENT (lessergy for 1 or 2 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reportedly consumed lots of fluids as treatment.  It was recommended to her that she drink Gatorade.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Chills (with shaking) and hot spells; muscle and joint pain, arms and legs bilaterally; upset stomach; difficulty breathing (lasted about 10 minutes): felt bad for about 18 hours.
Pt stated that his arm was red and swollen around injection site and that he felt not quite himself since getting vaccine.
After the vaccine only mild headache and mild muscle joint ache. But then a few weeks later I went to ER on November 29 and the doctor did a chest X-ray, CT scan of the brain, lab test and he said everything was normal, he did three COVID-19 tests and two came normal, he discharged me but later my PCR test came positive. I went to Cardiologist on January 2nd, 2023 and he said my pain was a result of a COVID. Tomorrow I will go to Rheumatologist for a checkup. I wasn't treated for COVID all this time.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/1/2022 &  1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recvd vax; mom states was warm last night,no fever; gave apap every 3-4 hrs; pt drinking a lot but not crying; sleepy & a little cranky; pt feeling better now;
Patient was 16 at the time of vaccination.  The clinic had shifted from a Pfizer only location to a Janssen only location for several days and the registration staff and vaccinator did not catch that the patient was not eligible for Janssen.
Moderna COVID-19 Vaccine EUA Achy and blah feeling started 9pm day of vaccination. Went to bed with very strong chills through body.  Awoke multiple times until got out of bed at 4am. Temp of 101.6. Headache, Mild nausea, injection site pain, body aches. One vomit around 3pm after trying to eat applesauce.  Fever broke and all symptoms resolved by 11pm.
Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. Chewed up inside of mouth until bleeding. On day three and symptoms slowly leaving. Now slight headache and extreme fatigue.
Pt vaccinated with Engerix-B developed fever, headache, nausea.
Sore from shoulder to elbow, pain increases when arm is raised above shoulder and when touched.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot#N000237 with expiry date:25-OCT-2019,lot#N003698 with expiry date:31-OCT-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA009615:
Complaints of feet going numb and traveling upwards towards midsection. Neurologist contacted and prescribed IV steroids for 3 days and oral medications for a week.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: briefly fainted but able to talk-Mild, Systemic: Nausea-Mild, Additional Details: pt received vaccine.. appeared ok first few minutes.. walked to front of store to get drink and when he came back to register said a little light headed and had some nausea. i asked him to sit and observed him for a few minutes. He did not appear pale,sweating or otherwise distressed. As I begane to give a second pt a shot he said he felt he was passing out. I ran over and partially caught him but he still hit his head on floor.  I had tech call 911 immediately as I monitored his signs.
About 15 minutes later my face, neck, and chest flushed bright red and felt semi numb and like ants were crawling on me. My chest was also tight but no trouble breathing.   Then ever since I?ve been nauseous. I?m rarely nauseous.
About 10 hours after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, I began experiencing noticeable soreness in my upper left arm around the injection site, extending in a 2-3 in radius. The soreness lasted some 14-16 hours and was noticeable with virtually any movement of my arm. It was not incapacitating and didn't seem threatening or dangerous, but since this vaccine is so new, it seems useful to report any and all side effects. Timeline:  1. Vaccination received at 11:00 A.M.;  2. Soreness began around 9:00 P.M. (possibly as late as 10:00 P.M.); 3. Soreness ended between 12:00 P.M. (noon) and 1:00 P.M. the following day.