chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA dose given 11 days after BUD for refrigeration.
Knees swells and broke out in rash like hives within 24 hours after shot. The rash is still on knees but less as of date 2-11-10.
Nausea, pain in arm, later pain increased and whole body ached.  Lasted for 36 hours.
Fatigue, Sore arm for 3 days, swollen axillary lymph nodes, headaches
Red warm tender macular ring developed around the site of the injection which increased in size over the 2 days after the injection.  Patient also got a fever.
Vaccine administered 4/5/21 at 7WGA and fetus stopped growing at 7w1d (4/6/21) Miscarriage completed 4/20/21
felt weak; Congested; Coughing; could not walk for 3 days; Felt very sick; High fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days) and MALAISE (Felt very sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days), MALAISE (Felt very sick), PYREXIA (High fever) and CHILLS (Chills). On 05-May-2021, MALAISE (Felt very sick) and PYREXIA (High fever) had resolved. At the time of the report, ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing) and CHILLS (Chills) had not resolved and GAIT DISTURBANCE (could not walk for 3 days) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient reported that a few hours after second dose of vaccination she experienced high fever, felt weak, could not walk for 3 days and had to visit the emergency room. Patient's congestion with coughing, weakness and chills was not resolved.  Patient has taken Tylenol and Tylenol PM for the treatment.
Since receiving my first Covid vaccination injection one full month ago, I continue to have muscle pain and soreness at the injection site. My next shot is scheduled in 3 days. My doctor is out of town and I'm unsure about getting the second shot since I'm still having side effects from the first shot.
vaccinated / with a non-approved diluent; Menveo reconstituted with a nonapproved; This case was reported by a nurse via call center representative and described the occurrence of incorrect dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA399A, expiry date 30th September 2021) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Menveo. On 13th August 2021, unknown after receiving Menveo, the patient experienced incorrect dose administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the incorrect dose administered and wrong solution used in drug reconstitution were unknown.  Additional details were provided as follows: The reporter stated that, the patient vaccinated with the powder portion of Menveo reconstituted with a non approved diluent, which led to  incorrect dose administered and wrong solution used in drug reconstitution.  The reporter consented to follow up.
I saw the doctor on March 2 and was diagnosed with tonsillitis and an ear infection by the next week on March 8 I was having severe anxiety, depression and mental health issues.  I was treated with medication and saw a therapist which helped. I have not felt well since March and was admitted to the hospital on May 18 with severely elevated liver function tests and was diagnosed with drug induced liver injury.  I am better after they adjusted my medications but I continue to feel exhausted and I can sleep 12 hours and still not feel rested.  I can get up in the morning feeling good and within 2 hours I am completely worn out and this has caused my depression and anxiety to reoccur.  I just want to figure out what is wrong with me so I can get back to my normal life and not feel like I'm struggling to do normal activities of daily living.  It has effected my personal and my professional life because of feeling horrible everyday and missing so much work due to my mysterious illness.
First dose administered 10/2019.Second dose not yet administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The nurse reported that the second dose of Shingrix was not received till the time of reporting, which led to incomplete course of vaccination. Nurse reporting second dose of Shingrix greater than 6 months. Lot number and expiration date unavailable per health care professional. Day of month not available. The reporter consented to follow up.
At 10:35 attendee had complaints of nausea and dry heaves. Fireman notified. Vital signs at 10:37: blood pressure 148/84, pulse 79, temperature 97.8F, respirations 22, O2 sats 100% on room air. Attendee had complaints of throat feels tight and attendee noted to have jittery hands. Cold pack applied to back of neck. Attendee provided with emesis bag. Attendee had only dry heaves. Vital signs at 10:45am, Blood pressure 119/83, pulse 72. Attendee reported feeling better and declined trip to urgent care/hospital. Attendee instructed to go to urgent care and/or primary care physician if has further symptoms or concerns. Attendee declined further assistance and left fire station at approximately 1100AM.
suspected vaccination failure/ got the vaccine and still got shingles; still got shingles twice afterwards; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's family member. The age at vaccination was not reported. The patient got the shingle shot and still got shingles twice afterwards. The reporter stated that buyers should beware. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
I had administered the vaccine to the patient today. She stayed in the post-vaccination area for the full 15 minutes after her dose. She then left with her family & went walking around the store to shop. After about 5 minutes she returns to the clinic and let me know that she felt she was reacting to the vaccine. She described her symptoms as if she had just ran a marathon, she had palpitations and felt extremely fatigue suddenly. I sat the patient down in the post-vaccination area and took her blood pressure, with a reading of 188/88 and got her pulse, with a reading of 96. The patient's daughter brought her some water and after some questioning, patient revealed that she had not eaten for the last 8 hours. She was able to eat a protein bar while I was with her and drank some water. I observed her for about 25 minutes, and after then, she felt better, her daughter was going to be driving them home so I then released her, as she felt oriented, alert and her chest pains had subsided.
This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. None concomitant medication, pertinent medical history or drug allergies or reactions were reported. On 18-APR-2016, the patient was vaccinated with GARDASIL 9 (0.5 ml, once, lot # L043213, intramuscularly). Other suspect therapies included MENACTRA and BOOSTRIX (both administered on 18-APR-2016, dose and route were not reported). The physician reported that on 18-APR-2016 (after the patient was administered these vaccines), he experienced a "syncopal episode". The patient was sitting on the examination table and went down to the side. The physician reported that the patient was down for a little while and then woke back up. The physician kept the patient in the office for a half hour and gave him juice and candy as treatment for the syncopal episode as the patient had skipped breakfast and lunch. Lab diagnostic studies were not performed. The outcome of syncopal episode was reported as recovered on 18-APR-2016. Causality assessment was not reported. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-AUG-2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 24-SEP-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient noticed the site of injection was red the morning after the injection (04/02/2016).  The area was a little itchy but mainly red. The redness decreased over the next 2 days and was completely resolved by 04/05/2016.  No treatment was given.  Benadryl was recommended.
4-10 and 4-11 experienced leg pain in left calf. When laying in bed moved up back of upper leg. Tylenol helped but only 3 hours. Took ibuprofen next nigh, helped overnight. Symptoms resolved by  morning.
Itchiness, welt on left eye lid approximately 30 minutes after injection. Welt resolved about an hour later on it's own. No anti-allergy medications taken.
Applied hydrocortisone cream and 3 days later area was clear. Urticaria pruritus and red, warm swollen at injection site four inches in diameter. Hydrocortisone apply TID.
After Gardasil #3 woke up with shoulder pain L  now hands fingers hard to work.  Tests for lupus & arthritis - neg.  Now very stiff joints hands & knees.  Vague history when sym started.
Received MMR, varicella, DTap, polio on 02/22/2002. Pt noted hives a few hours later
Patient was at the pharmacy to receive the Bivalent Moderna Booster for Peds however received the primary series of the Moderna Covid Peds vaccine. Parents did not report any adverse events from the vaccine.
Initial unsolicited report received from a medical assistant on 06-Jul-2018. This case involves an eight months old male patient who was vaccinated once with an 0.5 ml expired dose of PENTACEL (batch number: C5188AA, expiration date: 12-Mar-2018, dose in series was not reported) via intramuscular route on 12-Mar-2018 by mistake. The patient's concomitant medications include HEPATITIS B VACCINE, PNEUMOCOCCAL 13 VALENT VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. It was not reported whether the patient had experienced any adverse events or not. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
experiencing brain fog from the first vaccine; achy; fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (experiencing brain fog from the first vaccine), PAIN (achy), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease, Thrombus and Pneumonia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (experiencing brain fog from the first vaccine), PAIN (achy), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (experiencing brain fog from the first vaccine), PAIN (achy), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Shortness of breath; Nausea; Lightheaded; Blurry vision; Confusion; Bed sick for five weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2021 as dose 2, single (Lot number: EW0167) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; "Known allergies: contrast" (unspecified if ongoing), notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. The patient's concomitant medications were not reported. Past drug history included: Wellbutrin for drug use for unknown indication, reaction(s): "Known allergies: Wellbutrin", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast; Ambien for drug use for unknown indication, reaction(s): "Known allergies: Ambien", notes: Known allergies: PCN, latex, Wellbutrin, Ambien, contrast. Vaccination history included: BNT162b2 (Dose 1, (PURPLE CAP) SINGLE, Location of injection: Arm Left, Batch/Lot No: ER8731), administration date: 16Apr2021, when the patient was 59-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Bed sick for five weeks"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; NAUSEA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheaded"; VISION BLURRED (non-serious), outcome "unknown", described as "Blurry vision"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "Confusion".  Additional information: Patient reported the second shot had her in bed sick for five weeks. She had shortness of breath, nausea, lightheaded, blurry vision and confusion. She understood they felt like the vaccine did not have adverse effects, but it does. Everyone's body/DNA isn't the same. What doesn't affect one person will effect another one. Unfortunately, she just happened to be one out of many that had got adverse side effects from the vaccine.
soreness and Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness and Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness and Pain in arm). At the time of the report, PAIN IN EXTREMITY (soreness and Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications were provided
Headache, Angioedema, jaw pain Narrative: facial swelling, H/A, and jaw pain. onset of symptoms around an hour after injection. Symptoms resolved after taking OTC Benadryl 50MG. Had similar reaction to Primogyn/estrogen.
Daughters has missed her period main event the COVID shot. She is very regular so this is not a normal reaction/event. Will wait a few more weeks and if it still has not come we will make a doctors appointment.
Mild rash varicella case. Epsom salts bath. Calamine lotion. Pt should avoid kids less than 1 yr old, pregnant females. Per pt dad pt. started to develop a rash all over her body since yesterday. Pt. got vaccines on 7/31/14 and parent is wondering if it's a reaction to the vaccines. Pt has also been coughing x1 day. Pt woke up last night 4 times and normally she sleeps through the night did notice she felt a little warm last night. Pt also has a runny nose. Patient recently did receive varicella vaccine. Rash started on trunk. Patient is eating well.
Onset 04/08/2022 Right side C-8 Herpes Zoster
The vaccine was stored  longer than the 10 weeks duration in the fridge. It was administered to the patient 4 days after the 10 week date.
No additional AE reported; GARDASIL 9 had involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had been involved in multiple low temperature excursion of 35 degree  Fahrenheit(F) for 0.25 hour (on 03-NOV-2021), 0.75 hour(on 04-NOV-2021), 0.5 hour(on 05-NOV-2021) and 0.25 hour(on 12-NOV-2021), respectively. The previous excursions were unknown. On 12-NOV-2021, the patient was vaccinated with the improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # T030749, expiration date 16-MAR-2023; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error). No additional adverse event (AE) was reported, and no further information provided.
The pt experienced a fever of 104, convulsions, chills. The pt went to the ER.
Pt called pharmacy around 7 or 8 pm on 10/21/20 after receiving her vaccine around 11:15 am. She reported that she was experiencing light headedness, headache and weight on her chest. Breathing was made easier with use of oxygen. Patient had increased pressure with laying down versus being vertical. Pt was taken to hospital 20-30 minutes after phone conversation. Full outcomes unknown at this time
Pt. had a reaction to varicella vaccine on (L) upper thigh. Welt returned to (L) thigh after 8 days, post vaccine. Fever also returned.
in May a week after he got the second pfiser covid vaccine he got tingling in all his limbs, tremors in hand, tongue and jaw, swallowing problems. The fatigue ebbs and flows and get worse with exercise and stress.  He can have twitching in his legs if he sits down after an argument. The fatigue is worse the last 2 weeks.  He works in Finance. He lives in the city does sales and training. He grew up another State . He came home during the shut down as working from home, he mainly works from home.  He got a covid ab test 2 days ago that is still pending from lab  He is constantly tired, and small levels of physical activity or stress tend to wipe him out. He is sleeping ~9 hours a night, and averaging 2 or 3 naps a day totaling at least another 1.5 hours.   He has a persistent tingling feeling in his entire body. It began right after the covid shot,  has spread to all limbs, and is constant. He has had 2 moments in the last week where he had no tingling, both in the middle of the night and for ~60 seconds total. These were the only two points in the last several months where the tingling has not been present.   He has developed tremors in both hands, his jaw, and his tongue. They get significantly worse with stress and activity. He also has some numbness in his feet and hands. Symptoms got significantly worse after the 2nd covid shot and have stayed elevated.
Moderna COVID-19 Vaccine EUA  Fever (99.8 - 100.4 F over course), body aches, chills - took 2 tylenol (650mg each)  about 1-2 hours after onset, symptoms resolved within 2 hours, temperature back down to 98.6F.
Report 20010063351 described heat, redness, and pain at the injection site in a five year old male who received DTaP. The vaccinee had no known drug allergies and medical history was denied. On 03/05/01, the vaccinee received his first right thigh dose of Infanrix, a right thigh dose of MMR, a left thigh dose of IPV and a left thigh dose of varicella vaccine. "Within 1-2 days" post-vaccination, the vaccinee experienced baseball-sized redness, heat, and pain at the injection site. An ER visit was required, and the vaccinee was given unspecified treatment on 03/07/2001. As of 03/08/2001, the outcome of the event is unresolved.
Janssen COVID-19 Vaccine EUA  Persistent ringing in the ears (tinnitus)
MCV4 site patient right arm (deltoid) near/around injection site was red and swollen. This area was measured to be 7X7 cm. This is improved from last night when mom noticed the reaction. Last night it was worse, more swollen and painful.
Acute onset of vomiting, nausea, and shortness of breath after one hour of immunization. The patient also reported drowsiness. The patient received Promethazine Orally. The patient was given 24 hours S/Q. The patient returned to full duty the following day.
pt recv vax & 12hr post vax pt exp hives on face & on back;24hr post vax pt exp hives & wheezing;ER or MD visit was required;tx DPH;sx resolved over 2 days;