chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe allergic reaction including throat swelling, hives, burning /itching skin (head to toe), swelling of hands and feet. Over a thirty minute span, the reactions started to the time I made it to the ER. They got progressively worse during that 30 minute span. Required a shot of epinephrine due to anaphylaxis.
Onset of pruritic maculopapular rash on trunk that spread to neck 55 hours after vaccination.  Responded to treatment with H1 and H2 blockers. No steroids required. No anaphylaxis noted.
On November 22 I woke up in a lot of pain, I felt like someone curb stomped my shoulder in the middle of the night. I went to the doctor. The Friday after the November holiday, I started having numbness and tingling in my arm and I thought it had something to do with my heart. The doctor ran EKG and X-ray's of my neck and shoulder. They found a pinched nerve. Unsure of the cause they referred me to a spine and pain management specialist. Followed up with some specialist and they could find the cause, so I was scheduled for an MRI this week. I am currently in physical therapy and taking a muscle relaxer (pregabalin). Plan on making a callback to update the report.
within the first 24 hours : ran fever for 15 hours, extreme fatigue, body and muscle aches within two weeks : excessive hair loss (clumps falling out daily)  within three weeks : changes to menstrual cycle, spotting on cycle day 19; not pregnant
edges seem to be irregular, a little lighter; Injection site redness/redness appeared around the site, getting larger; warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter) and VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D;VITAMIN E for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger). On 26-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter). On 25-Feb-2021, VACCINATION SITE ERYTHEMA (Injection site redness/redness appeared around the site, getting larger) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm) had not resolved and VACCINATION SITE DISCOLOURATION (edges seem to be irregular, a little lighter) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant products included 2x high blood pressure medication and cholesterol medication.  Patient has applied cold on and off for the treatment.  The action taken with mRNA-1273 in response to the event was not applicable.
Mother states on day 4 following the vaccines patient developed "welts/skin blotches/ hives all over his body" not aware of any fever or chills at that time. The parents did not seek any medical treatment, and this lasted for 3-4 days. Patient recovered from this episode.
18OCT-3PM severe abdo cramps lasting overnoc; digestive system not affected; lost 1 day of work; Thursday PM asthma flare-up; had to use inhalator; Friday PM broke out in hives around waist line;
I am Health Care worker (Security Officer) at Hospital. On 12/28/2020 around 9am I received my Covid Vaccine (1st) After the shot, I sat the required 15 minutes and felt no ill effects Around 530 pm. I was out shopping after work and almost passed out. It was not a gradual feeling -It felt more like someone had punched me in the head. I was too dizzy to walk for 30 seconds or so. After about 5 minutes I felt okay and drove home.  I feel absolutely fine today (12/29/2020)
Patient was administered with an expired act-hib vaccine with no A/E; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other Health Care Professional via consumer Reference number: 00750051).  This case involves a 23-months old male patient who was administered with an expired HIB (PRP/T) VACCINE [ACT-HIB] with no adverse event (Expired product administered).  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and hepatitis for prophylactic vaccination.  On 31-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ356AA and expiry date: 25-Jul-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "The caller is requesting recommendations for a patient that had received an expired ACT HIB vaccination. Emergency Room/Doctor's visit and date 8/31/2021."  Frequency: once.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
I had my second Shingrix shot around noon. That night I was shivering and freezing cold almost all night. Yesterday I felt like I was moving in slow motion and last night I sweated heavily. I feel better today, but my arm is very painful, red and swollen in an oval area about 6" x 5". After my first injection, my arm was sore for about a week, but not nearly as painful as this second time and I did not have any of the other reactions that I have described above.
hives; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult and unknown gender patient who experienced hives while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious "hives (urticaria)" (unknown latency) following the administration of influenza vaccine.  It was reported that "I've never had a flu shot in my life. I take vitamin C, Zinc, & D3 to build my immunity. I've heard from some people the flu shot makes you sick. It also made one of my friends break out in hives".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (hives).  At time of reporting, the outcome was Unknown for the event hives.
swollen arm; Rash on Arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm). On 12-Feb-2021, PERIPHERAL SWELLING (swollen arm) and INJECTION SITE RASH (Rash on Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Moderate allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had moderate allergic reaction after the first dose of vaccination. The outcome of the event, moderate allergic reaction, was unknown. The patient was concerned if she should take the second dose.  Information on the lot/batch number has been requested.
pt recv vax 12noon 9OCT97 exp feeling shaky, perspiring, throat closing @ 2PM;relieved somewhat w/DPH;sx recurred @ 4PM to ER & treated for anaphylactic rxn;
Approx 7 days post small pox immunization, pt experienced generalized maculopapular and mildly pruritic rash to ant/post trunk, upper and lower extremities.
big bump/bigger than a dollar coin; soreness over 24 hours; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 48, unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration dates were unknown), via an unspecified route of administration on 25Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had soreness over 24 hours on Dec2020. She was wondering if the person who administered it, administered it subcutaneous instead of intramuscularly. Since 25Dec2020 until 03Jan2021, there was a big bump. There was no pain when patient touched it but she felt like it's getting bigger. It wasn't as big. It's bigger than a dollar coin. It was like a raisin. Outcome of the event of big bump was not recovered while for the other event was unknown. Patient was not sure what size needle was used and went back to ask the nurse. When she drew the needle out, there was medication that.   Information on the Lot/Batch number has been requested.
Lymph node enlargement in throat beginning on day 5 and lasting until day 7 with underarm/breast involvement as well Fatigue on day 6 Body/joint aches on day 6, lasting until day 9
Patient reports severe muscle stiffness and pain that began in the neck and later radiated down through her back and leg  and lasted about one week
Approximately 20 minutes after DTaP/MMR/IPV in right deltoid. Pt had left tonic clonic generalized seizure; short lived 45 sec; post ictal around 10 minutes. Re-examined, observed in office. Only change was increase in DTR's symmetrical 3+ (NL only 2+) Rest of Naso=NL.
Around 09am on the 23 of October I woke up feeling pain all over my body fever with 99 degrees temperature. I was shivering and disoriented. Later in the evening I felt very nauseous and almost fainted. I quickly lay down it went away.  The next day I felt 60% better but I couldn?t focus.
a rash on the injection site of 2inches and red which gradually got less red in 4-5 days; low grade fever; flushing of her cheeks "apple red"; headache; fatigue; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), PAIN IN EXTREMITY (soreness of her arm), PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Thyroid pill for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm). On 15-Feb-2021, the patient experienced PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red"). On 18-Feb-2021, the patient experienced INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days). On 05-Feb-2021, HEADACHE (headache), FATIGUE (fatigue) and PAIN IN EXTREMITY (soreness of her arm) had resolved. On 23-Feb-2021, PYREXIA (low grade fever) and FLUSHING (flushing of her cheeks "apple red") had resolved. At the time of the report, INJECTION SITE RASH (a rash on the injection site of 2inches and red which gradually got less red in 4-5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
Starting the evening I received my vaccine, my R arm was extremely painful and hot. Over the next 2 days it got worse, severe swelling, redness, hot to touch, pain in arm and numbness. This disrupted my sleep, daily activities and work (unable to type with R hand/arm). This started to subside on day 3-4 but lasted almost 2 weeks until the pain/swelling was completely gone.
Patient developed a vasculitic rash on her lower extremities approximately 36 hours after receiving the moderna COVID-19 vaccination.  She also had a fever, bilateral ankle pain, malaise.  The patient was also on nitrofurantoin for a urinary tract infection.  The patient was hospitalized overnight.  Skin biopsy showed leukocytoclastic vasculitis.  In my opinion this was more likely related to the nitrofurantoin than the COVID-19 vaccination, although that possibility remains.  Care discussed with a dermatologist who agreed.  There is no test or way to sort out the causative agent.
Mild headache followed onset of uncontrollable shivering at approximately 10 pm in bed while sleeping accompanied by a low grade fever of 100.5 degrees. I took 500 mg of acetaminophen and drank some hot water with lemon and was able to control the shivering and fever. Several days of fatigue to follow. No other symptoms.
"COVID Arm" - Appearing just over a week after injection, a raised, sore, and hardened area of swelling at the injection site. Some itchiness. Has lasted over 24 hours but no other symptoms or discomfort.
Patient / side effect / called out to work due to fever 99. to 100.4; chills, nausea, fever, body aches (5/10, from 8/10)  / called out from work due to 100.8 fever / feeling better at the time of call / severe arm pain (6/10, from 8/10)
Shortness of breath/suddenly she could not breathe at all; took like 7 liters of fluid out of her lungs/her lungs were filled up with fluid; Patient received 3rd dose and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA and DYSPNOEA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PULMONARY OEDEMA (seriousness criteria hospitalization and medically significant). On 20-Sep-2021, the patient experienced DYSPNOEA (seriousness criterion hospitalization) and OFF LABEL USE (Patient received 3rd dose and was not immunocompromised). The patient was hospitalized on sometime in September 2021 due to DYSPNOEA and PULMONARY OEDEMA. On 20-Sep-2021, OFF LABEL USE (Patient received 3rd dose and was not immunocompromised) had resolved. At the time of the report, PULMONARY OEDEMA and DYSPNOEA outcome was unknown.            Reporter mentioned that the only concomitant medication was the diuretic. Treatment medication given as Diuretic and Oxygen.  Reporter mentioned that the patient was put on a ventilator. Her mother is usually active and independent. She said her mother was not immunosuppressed. She was having shortness of breath and saw her cardiologist in August and had a chest X-ray and had another appointment for the cardiologist in September. Patient was not able to breath. The paramedic got here, put all those monitors on her, she could not breathe. Then she was in the ICU on a vent, that was on Monday night. Then she got off the vent and now she's on oxygen. She drives, she had gone to a funeral out of town that day. Her daughter said that if our Safety department can't talk to her because of HIPPA that she has a medical power attorney and also her mom is talking now (she could not talk before because she was on a vent).  This case concerns an 81 year-old female with no medical history provided, who experienced the unexpected event of Pulmonary Oedema and Dyspnoea. The event of Pulmonary Oedema occurred sometime in September, while Dyspnoea occurred on the same day as the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
Pain (3/10) in left neck and lower jaw at rest, increasing with movement, talking, or swallowing. Radiating locally to neck and mouth and tender to touch lasting 2 days. Onset of symptoms 48 hours after vaccine administration. Some tingling and paraesthesia for about 5 hours.
Patient with symptoms of burning and tingling initially lasting 1-2 minutes 2-3 times per day about 4-5 days after first vaccination.  On 2/11, concern for increase in symptoms - episode of 5 minutes of itching - spreading down arms and into stomach.
At HS mother noted red "rash" on child's abdomen. She applied Benadryl cream. At approx. 3 am the child's "rash" had spread to entire body, head, face, ears, arms, legs. Child was seen at local ED this am and given "2 cortisone shots" and RX- Orapred 15mg/5cc, 1 tsp po q daily x 5 days.
Fever; Headache; Achy Bones; Tiredness; Cough; Start Date/Time: 22Dec2020 04:00 AM; Dose Number:1/Start Date/Time: 08Jan2021 08:45 AM;Dose Number:2; This is a spontaneous report from a contactable other HCP reporting for herself.  A 52-years-old female patient received the second dose of  bnt162b2 (BNT162B2) vaccine , on 08Jan2021 08:45 in the left arm at single dose  for Covid 19 immunization.  Medical history included drug hypersensitivity   Concomitant medication included lisdexamfetamine mesilate (VYVANSE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ergocalciferol (VIT D).  The patient received the first dose of BNT 162B2 vaccine on 22Dec2020. On 08Jan2021, the patient received the second dose of BNT162B2 vaccine earlier than expected. On 09Jan2021 the patient experienced fever, headache, achy bones, tiredness, and cough The reported events were considered non serious and their outcome was recovering  No follow-up attempts are possible: information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to a 12 month old male patient. There was no medical history or drug reaction/allergies reported. On 24-AUG-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # K007983 with expired date 03-JUN-2016, 0.5 ml) subcutaneously in the right arm. The vaccine was improperly stored. No concomitant medication was provided. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
shingles; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included chickenpox (when the patient was a child) and fruit allergy (mango fruit allergy). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), hydrocodone bitartrate and paracetamol (NORCO) from unknown dates taken for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 13:00, the patient experienced breakout of the shingles virus. The event resulted in emergency room/department visit or urgent care, but there was no diagnosis for the rash on face. Therapeutic measures were taken as a result of the event which included treatment with Amoxicillin. On 03Apr2021, the patient again returned to the urgent care as the symptoms were getting worse and they diagnosed the patient with shingles which was confirmed by the urgent care facility. It was stated that the patient has no prior history of shingles. Therapeutic measures were taken as a result of shingles which included treatment with valacyclovir 1 gm tablet AUR three times a day for ten days. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine administered to a pregnant woman; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-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 an unknown date and the estimated date of delivery was 15-Jun-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy