chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at the injection site; Pain at the injection site/painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and outcomes provided by reporter, 2nd dose taken and no event after 2 nd dose. Reporter not interested in further FU.
feeling lnocked out for 3 to 4 days; headache; feeling tire; injection site arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling lnocked out for 3 to 4 days), HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, the patient experienced FEELING ABNORMAL (feeling lnocked out for 3 to 4 days), HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts). In September 2021, FEELING ABNORMAL (feeling lnocked out for 3 to 4 days) had resolved. At the time of the report, HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts) outcome was unknown.            Concomitant products were not provided. Patient reported of  feeling knocked out for 3 to 4 days. Treatment medications were not reported.   This case was linked to MOD-2022-526422, MOD-2022-526426, MOD-2022-526395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up received contains non significant information.
Quick onset of mild chest pain and tightness that extends into the throat. Symptoms get worse with exertion.
No Adverse event; expired dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose was administered) and NO ADVERSE EVENT (No Adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 054B22A and 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 09-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose was administered) 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 EXPIRED PRODUCT ADMINISTERED (expired dose was administered).    Concomitant medication was not reported. The patient didn't report any side effects. Treatment drug was not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: J3274) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2023) Diagnosed with COVID, notes: Diagnosed with COVID 22Aug2023; (28Aug2023) Negative; (29Aug2023) Negative; (01Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: product: Paxlovid Taken as COVID 19 Treatment; treatment start date: 22Aug2023; treatment stop date: 26Aug2023. Diagnosed with COVID 22Aug2023. This was the first time I had ever gotten COVID. Began Paxlovid same day (22Aug2023). Took full course. Began to feel better, tested negative on 28Aug2023, 29Aug2023 and was continuing to feel better each day. Began to feel sick(er) 31Aug2023. Tested positive 01Sep23.
Blurred vision due to central RetiNal VeiN occlusion uccured 1 week after 1st Pfizer COVID 19 vacc on 2/10/21
bruising on abdomen; bump above left eyebrow; left eye was completely black and swollen shut, closed over like angioedema; left eye was completely black and swollen shut, closed over like angioedema; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema), SWELLING FACE (bump above left eyebrow), CONTUSION (bruising on abdomen) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema). On 20-Nov-2021 at 2:00 AM, the patient experienced SWELLING FACE (bump above left eyebrow). On an unknown date, the patient experienced CONTUSION (bruising on abdomen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE CONTUSION (left eye was completely black and swollen shut, closed over like angioedema), SWELLING FACE (bump above left eyebrow), CONTUSION (bruising on abdomen) and EYE SWELLING (left eye was completely black and swollen shut, closed over like angioedema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient saw PCP doctor who ruled out angioedema. Gets monoclonal antibodies and suspects clotting or bleeding issue for bruising of abdomen. Patient was instructed to do cold compress and Tylenol. Patient was told this is impact injury.
This spontaneous report was received from a Registered Nurse concerning to a 24 year old female patient. This was a prospective pregnancy report. The patient's medical history included: asthma, bulimia nervosa, migraine and tobacco abuse. Concurrent conditions and concomitant therapy were not reported. On 26-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L016428, expiration date: 30-JUL-2017, injection. Strength and route of administration were not provided. The same day the patient was also vaccinated with PNEUMOVAX 23 lot# L048265, expiration date: 10-JUN-2017, injection. Strength and route of administration were not reported. On 03-OCT-2016 the patient returned to the office and was administered an unspecified pregnancy test, which exhibited a positive result. Registered Nurse stated the patient was found to be 5 weeks pregnant that day. Initial exposure to GARDASIL 9 and PNEUMOVAX 23, was at 4 weeks (first trimester). No adverse effect was reported. The patient became pregnant with last menstrual period (LMP) of 28-AUG-2016, estimated date of conception of 11-SEP-2016 and estimated date of delivery (EDD) of 04-JUN-2017. It was the patient's first pregnancy. The pregnancy outcome was pending. Additional information has been requested.
Patient looked pale and said she was dizzy and lightheaded a little sweaty.  She also was breathing more heavily than expected.  We got her an ice pack to hold on her head and neck as that felt good to her and some apple juice to sip on.  We got her feet up and had her sit back and as time went on she said she was feeling better.  We called a caregiver to pick her up and drive her home.  She was probably in the waiting room for about 45 minutes during this episode waiting for her caregiver to arrive. She already had a walker and her caregiver already had a transport chair for her in his car.   She was able to get in transport chair and leave with her caregiver/ family member.  I called her back around 6:30 this evening to check in and she said she was doing ok, still a little tired and fatigued but doing ok.
1 day following shot, had swelling in injection site and redness. This dissipated. Then, 7 days later, injection site began to become itchy and there is swelling (feels like a knot) and red rash at area.
Fatigue and body aches the day after. Rash at injection site second day after persisting for 2 days. Clear by fourth day after.
Intense chill and shivering occurred three times the day after the vaccination - at 4:30am, 2:00pm, and 7:30pm; I took ADVIL each time which seemed to help. Lingering chills occurred two days after the vaccination, but much reduced. I also experienced muscle fatigue and headaches the day after the vaccination; the ADVIL definitely helped relieve these.
Hair has not grown since; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A71A and 00FM201) for COVID-19 vaccination.     Concomitant products included ATENOLOL, CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), ALENDRONATE SODIUM (FOSAMAX), LISINOPRIL, METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), SIMVASTATIN and SERTRALINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain). At the time of the report, HAIR GROWTH RATE ABNORMAL (Hair has not grown since) and MYALGIA (Muscle pain) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Big red rash the size of an exlarge lemon.  Still there after 3 weeks from injection.  Have not taken any medicine for this reaction. The redness has faded some, but still the majority is still present.  Other reactions, almost instant swollen, hard lump, severe soreness, headache, nausea and fatigue for several days. Headache for a week.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19). In February 2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   It was reported that the patient would not take anymore doses. The patient came down with COVID-19 that put patient seriously down enough from Christmas eve 2021 until 2nd week of Feb-2022. The patient took strong natural herb tea.   This case was linked to US-MODERNATX, INC.-MOD-2023-698001, US-MODERNATX, INC.-MOD-2023-698006 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698001:Case for daughter US-MODERNATX, INC.-MOD-2023-698006:Case for Granddaughter
SCATTERED ERYTHEMATOUS PLAQUES APPROX 2-3 CM DIAMETER WITH A CENTRAL WHEAL OF 5MM,  THESE ARE LOCATED ON LOWER EXTREMITIES AND ABDOMINAL AREA WITH A FEW SPREADING TO UPPER EXTEREMITIES.
Headache, Myalgia, chills and shakes, sore arm Narrative:   Other Relevant History:
Generalized small macular papular rash appeared approx 14 days post inject w/Rubella vax; Seen in ER by MD on 12APR91;
This medically confirmed report (initial receipt 04-Dec-2012) concerns a 20-year-old-female patient. On an unspecified date the patient received influenza vaccine (manufacturer and batch no. not specified) and PNEUMOVAX 23. On 24-Oct-2012, she experienced a bad allergic reaction which resulted in hospitalisation. The patient's heart stopped. She experienced seizures, headaches and had elevated liver enzymes. She remained in hospital for 9 days. The patient requested compensation for her medical expenses. The outcome for the event was not recovered.
Developed rash on left arm near site of the injection. The rash spread down the arm and up the shoulder and stayed for about a week.
1st Day - fatigue, swelling and pain at injection site, slight headache, low grade fever, difficulty sleeping, joing pain, body aches 2nd Day - fatigue, swelling and pain at injection site, headache, joint pain, body aches 3rd Day - fatigue, mild swelling at injection site, joint pain, body aches
"Pfizer-BioNTech COVID-19 Vaccine EUA" woke up feeling generally unwell, fever of 100.5 and fatigue. Resolved by the next morning of 1/2/2021.
got tired after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (got tired after the first vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (got tired after the first vaccine). At the time of the report, FATIGUE (got tired after the first vaccine) outcome was unknown.            No treatment details were provided by reporter.  Her blood test from 20-Aug-2021 shows that she has 0.4 non-detectable SARS-Co-V-2 antibodies .   This case was linked to MOD-2021-302110.
Diffuse rash - began as papules which became vesicular - involved scalp, trunk, and proximal upper & lower extremities.
Light-headed, dizziness after receiving vaccination  Vitals: BP 125/76 HR 84 Resp 16 O2Sat 96  Skin Signs: Warm and dry  Circulation: 2 Respiratory: Breath sound clear bilaterally  Initial Treatment: Moved patient to triage. Put patient in supine recovery.  6:20 PM  Vitals: BP 121/78 HR 80 Resp 16 O2Sat 99  Skin Signs: Warm and dry  Circulation: 1 Respiratory: Breath sound clear bilaterally  Notes:  Patient stated he was feeling better and moved into seated position. Patient advised to seek further medical attention if symptoms returned/worsened.
began fever at 8 hrs post injection, body aches, headache, skin sensitivity, fever for 24 hrs after injections.
This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu vaccine for prophylaxis. Co-suspect products included BENLYSTA unknown for an unknown indication. On an unknown date, the patient received Flu vaccine. In January 2019, the patient started BENLYSTA at an unknown dose and frequency. On an unknown date, unknown after receiving Flu vaccine and not applicable after starting BENLYSTA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and injection site pain. (Dechallenge was unknown). Rechallenge with BENLYSTA was unknown. On an unknown date, the outcome of the vaccination failure, influenza and injection site pain were unknown. It was unknown if the reporter considered the vaccination failure, influenza and injection site pain to be related to Flu vaccine. It was unknown if the reporter considered the influenza and injection site pain to be related to BENLYSTA. Additional details were provided as follows: The age at vaccination was not reported. The patient received the first 2 doses of BENLYSTA but had to stop because she had the flu. She stated that she had received her influenza vaccine. She also reported that the infusions were painful. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
Right after the first and second shot, my tongue was numb and tingly.  After my first shot on April 15, i had a very sore arm. Days later i had swelling around the mouth and my left ear had strange feeling. I didn't connect the symptoms with the shot at the time.  After my second shot my symptoms started May 14 early morning with fever, aches and headache lasting until late sunday, May 16.  On Monday, May 17 the swelling and itching around the mouth, nose and eyes. My tongue was numb, swelling and tingling. My throat was tightening but i could swallow ok.
Face broke out into a rash that was so painful, I could not move my face without it feeling like glass was in my face. Currently I am still experiencing great pain with my arthritis I feel stiffer than the tinman without oil. I also have been having dull pain every now and again in my right side that started once I got my shot.
The next night after getting my 2nd dose the upper part of my arm swelled 3 times the size of my arm normally. The very next morning I woke up to my whole arm hurting and being swollen down to my wrist.
Feels like going to bed; Feeling tired; Headache; Bodyache; Shaking; Nausea; Shortness of Breath; Chill; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), CHILLS (Chill) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced TREMOR (Shaking), DYSPNOEA (Shortness of Breath), CHILLS (Chill), PYREXIA (Fever) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Bodyache). On an unknown date, the patient experienced SOMNOLENCE (Feels like going to bed) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), SOMNOLENCE (Feels like going to bed), DYSPNOEA (Shortness of Breath), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Bodyache) and FATIGUE (Feeling tired) outcome was unknown, CHILLS (Chill) had not resolved and HEADACHE (Headache) had resolved.            Concomitant medication use provided by the reporter included blood pressure medication.  Action taken with the product mRNA-1273 is not Applicable.   Reporter did not allow further contact
Patient developed hives over left side of face and over body 1 day following administration of Flu vaccine.
Three days later, I noticed that my arm was itchy at the injection site. There was a faint rash. The next day it was not itchy anymore but the flat, faint rash was still there, the following day I again experienced itching and the rash was more pronounced. Today, 1/28/21, I woke up with itchyness again and saw that the rash is larger and raised.
"Pfizer-BioNTech COVID-19 Vaccine EUA" was administered to my daughter at her 2:40 pm appointment. She began feeling "down" at roughly 9:00 pm that evening. By roughly 3:15 in the morning of 12/02/2021 she was in my room telling me she felt sick. She then promptly ran to the bathroom and vomited. She felt very hot, shaky, and dizzy. She's been resting. It is now 12:32 pm on 12/02/2021 and while she is feeling better already, she is still not at 100%. She is complaining of a headache and is still slightly warm, but her temperature is only elevated, and she no longer has a fever. She has not vomited since last night. She is also complaining of minor body aches. She seems to be recovering well on her own.
3:50pm tongue and lips were feeling swollen, numb, and tingling, body as a whole felt odd (like she could faint), 3:52pm gave her 25mg oral liquid benadryl, 3:54pm b/p was 129/84 and pulse was 74, 3:56pm symptoms dramatically improved, but were not gone, 4:05pm slight numbness and tingling of lips and tongue, 4:22pm blushing of face and tingling of tips of fingers, 4:23pm gave another 25mg oral liquid benadryl, 4:32 gingling improved , but not gone, 4:34pm b/p 132/77 pulse 68, 4:38pm blushing almost gone, 4:39pm tingling in finger tips gone, 4:53pm no change-still slight numbness and tingling of lips and tongue, 4:55pm parents arrived and followed  my recommendations and took her to the emergency room, she was treated (unknown), then released with prescriptions for benadryl 25mg and a medrol dose pak.
sore arms, nausea, dizziness 20min p/vax;progressed to gen joint aching, malaise, fever x 4 days;MD stated must be a reaction to hep vax;