chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the Moderna vaccine in January/February and just tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On an unknown date, the patient experienced COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid). At the time of the report, COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Moderna vaccine in January or February. No concomitant product reported by reporter. No treatment medication reported by reporter. This case concerns a patient of unknown gender and age with no details on previous relevant medical history, who experienced the non serious unexpected event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 8 months after the dose of Spikevax, dose number unknown. The rechallenge is not applicable, since the only event reported was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not captured since information regarding the schedule of vaccination is lacking.; Sender's Comments: This case concerns a patient of unknown gender and age with no details on previous relevant medical history, who experienced the non serious unexpected event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 8 months after the dose of Spikevax, dose number unknown. The rechallenge is not applicable, since the only event reported was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not captured since information regarding the schedule of vaccination is lacking.
During observation patient states he felt faint then collapsed. RN standing nearby helped assist member to the floor. No injuries noted. Patient was monitored for an extended period of time. Vital signs stable.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates in November 2016 (reported as since 05-NOV-2016), the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 injection, lot # M041394, expiration date 23-MAY-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Product quality complaint was not involved. The administered doses of PNEUMOVAX 23 were stored in the temperature of 14.6 degrees Celsius for 62 hours. There was no previous temperature excursion. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Ear ringing that is high pitched, very loud, and constant. I have tried chiropractic care, massage therapy treatment, and audiology treatment that included hearing aids to help mask the sound. Nothing has given long-term relief. I also have tried home exercises that help briefly but the tinnitus always returns very quickly.
KNOTS IN THE SITE OF INJECTION; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1a08609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced knots in the site of injection, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of nausea and knots in the site of injection was not reported. This report was non-serious.
Soreness at the site of the injection; Red welt at site of the injection; A spontaneous report was received from an other reporter (unspecified) concerning a patient of an unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain and erythema.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to onset of the events, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced soreness and red welt at site of the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events soreness and red welt at site of the injection was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-003087:cross linked case Patient CB
This spontaneous report as received from a physician via company representative refers to a 18 month old patient of unknown gender. The patient's medical history included pre-existing heart condition. On an unknown date, the patient was vaccinated with a dose of M-M-R II (expiry date, lot number, route and dose were not reported). On an unknown date, the patient experienced swelling behind the left ear. The patient sought medical attention(unspecified). The physician indicated that the patient was hospitalized(date was unspecified) due to the event but had not disclosed if the hospital stay was overnight. On an unknown date, the event of swelling behind the left ear was recovered. Additional information has been requested.
Patient experienced a near syncope / fainting episode minutes after a flu and Pfizer Bivalent Booster vaccines co-administration. Patient recovered right away.
Rash. Approximately 6 days after immunization. Benadryl Q 4 hrs, PRN. No other treatment.
Short of breath, tightness in throat (anxious). 138/90, tachy, lungs clr.
Woke up and went to bathroom. Had diarrhea and vomited. Skin became clammy and was excessively tired. Felt extremely weak and tired all the next day.
pt recvd vax & 3 days later pt devel an allerg rxn characterized by hives, angioedema, tightness in the chest, & wheezing; pt was treated in ER w/SOlumedrol IV, Zantac, Sus-phrine, & DPH & the rxn resolved;
Woke at 11:30 pm on 1/21/2021 unable to breathe, gasping for breath, heaviness in the chest, severe body joint pain, headache, and nausea.  Took Flonase and ibuprofen and drank cold water to reduce inflammation in the chest for 20 minutes. Symptom relief.  Continued 400mg of ibuprofen q 6 hours for 48 hours.  1/23/2021 at 6:00 am fluid-filled ears, heaviness in the chest. Administered Flonase.Symptom relief after one hour.
Information has been received from a physician concerning a female in her 40's with asthma who on 07-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # not reported). Subsequently (on 07-OCT-2010 or 08-OCT-2010) the patient's arm became red and swelled at the injection site down to the elbow. The physician prescribed prednisone and BENADRYL. The outcome of the events was not reported. The patient sought unspecified medical attention. The events were considered to be other important medical events by the reporter. No further information is available.
About 10 minutes, I started getting really hot.  I had difficultly swallowing.  They gave me a shot of Benadryl.  The next morning, I wake up with chills, fever and body ache.  They went away after 12 hours.  Ongoing set fatigue and body aches.  General feel unwell. When to doctor, they did labs.  ANA level can back high.
muscle aches; flu like symptoms; arm pain /arm pain at the injection site/ Pain in arm worsening; redness /area turned bright red in a rectangle shape; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. On 26th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 27th October 2019, the patient experienced injection site erythema, muscle pain and influenza-like symptoms. On 29th October 2019, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The patient reported arm pain at the injection site the day of the vaccine. The following day the area turned bright red in a rectangle shape and she experienced muscle aches that she described as flu like symptoms. The redness lasted 3 to 4 days before fading and the muscle aches took a couple of days to resolve. The arm pain persisted and become worse. The patient refused to provide date of birth. The reporter consented to follow up. The outcome of the event pain in arm was reported as not recovered/resolved however in source document, it was mentioned as recovering/resolving.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. The healthcare professional reported that a couple of subjects had excessive injection site pain. Specific details regarding the subjects were unknown. The subjects reported the pain began after injection and lasted for a few days. The healthcare professional was uncertain if medical attention was required and reported vaccinations were administered at health clinics held at various facilities. At the time of reporting the pain at injection site was improved.
Adverse effect to Menstrual Cycle  After COVID Vaccine, mensural cycle has not stopped for 5 months
Red splotch on left arm at injection site; Injection site is hot; Injection site is sore; headache; fatigued; Injection site is itchy; A spontaneous report (United States) was received from a Health care professional concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy)     The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.   On 29 Jan  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A)  via  intramuscular route  on her left arm  for prophylaxis of COVID-19 infection.  Patient  developed a red splotch on the left arm at injection site and it feels hot, itchy and sore. She also had a severe headache  and feels fatigued like she had been ran over a truck . She had experienced these side effects for about 11 days. She expressed her frustrations about the side effects. Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy). at the time of the report, rash macular (red splotch on left arm at injection site), injection site warmth (injection site is hot), injection site pain (injection site is sore), headache (headache), fatigue (fatigued) and injection site pruritus (injection site is itchy) outcome was considered unknown.
Tdap given 4-3-15. LD. Pt noticed red swollen area at site of inj. Warm to touch. 3" area of swelling and redness. Taking ibuprofen.
Severe frontal headache started 15 min after vaccine and worsened. No associated symptoms.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: About 10 min after receiving the vaccine patient lost conciousness. Pharmacist assisted the patient and call EMS. patient regained consciousness in less than 15 seconds. Pharmacist noticed that patient voided on herself She was alert and oriented. She decided to call her parents who came to the pharmacy short after. Paramedic assessed the patient and noticed that the blood pressure was low. They gave the option to patient to take her to the ER which she declined.
48 year old female with past medical history of benign heart murmur and hypertension.  complained of heart racing and tingling in arm of side of injection. V/S taken at 15 minute interval reported as: HR 130/60-144/86, HR 94-114, RR 18-18, Temp 98, SP02 99%,. She was monitored and symptoms were intermittent. Patient insisted to be taken to the hospital because she didn't feel right. EMS called. Patient was observed and released with no necessary follow-up.
This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot# N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (19F). The previous temperature excursions were 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682; US-009507513-1805USA007507; US-009507513-1805USA007508; US-009507513-1805USA007509; US-009507513-1805USA007504; US-009507513-1805USA007510; US-009507513-1805USA007505; US-009507513-1805USA007506.
couldn't lift her left arm; Terrible headache; Fever (recorded temperature of over 101 at noon); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was provided.  Concomitant products included CITALOPRAM for an unknown indication.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)). The patient was treated with IBUPROFEN on 28-May-2021 at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 1 June 2021 contains no new information
Flu like symptoms; Weak; Pain all over his body; Tired; A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain all over his body general body pain, flu like symptoms/influenza like illness, weak/asthenia, tired/fatigue.  The patient's medical history was not provided. Concomitant medications reported were golimumab Infusion, Coumadin tablet, salbutamol/formoterol  Inhaler for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) pain all over his body, flu like symptoms, weak, tired.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain all over his body, flu like symptoms, weak, tired was unknown.
Blood shot and swollen eyes swollen throat, fever, sore throat, chills, muscle aches, fatigue, cough. H/A, muscle aches. Pt stated all symptoms on VIS.
p/vax pt had onset of red, vesicular rash on torso lt T6, axillar  upper arm;tired enough that had to stop competing in cross country x 2wk;pain onset 29SEP gone by 10OCT when rash mostly gone;no one else acquired varicella from pt;r
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Facial rash accompanied by burning pain and peeling.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 680 hours with lowest recorded temperature of 33 F(0.555555556 Celsius) and other one for 32 hours with lowest recorded temperature of 32 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
She received her 1st series of vaccinations. Rotateq orally then her injected shots (order unclear) IVP, Dtap, Prevnar, Comvax, 5 seconds, if that long, after last shot she went completely limp. No color, no apnea, vital signs stable, no seizure activity arousable after 30 sec, attentive after about 15 minutes.  3/15/07 Reviewed medical records from hospital which reveal patient seen on 2/14/07 after experiencing limpness s/p vax.  Initial VAERS report indicates vax given on 2/21/07.  T/C to reporter to clarify dates.  Stated vax were given on 2/14 & reaction occured same date.  VAERS database info corrected as such.  Patient was sent to ER & exam there revealed rapid resp rate but no distress.  Found to be hypotonic & intermittently arousable.  Admitted for observation after PCP discussed w/CDC.  No further episodes & progressed well.  D/C home after approx 8 hrs observation in hospital. FINAL DX: Probable adverse reaction to DTaP.
Rash two days after getting the covid vaccine..  The patient is a 61 year old woman who had her 1st Moderna vaccine (010A21A) on March 5th at 6:50pm, then on March 7th: started at midday with blanchable non itchy rash on upper arms, spread caudally to face, lost appetite- eating very little the last 2 days, wants ice, has a little nausea- had more yesterday, also tremor, dizziness, diarrhea same day, watery- x2 today, since day of vaccine. No known allergies, never had this prior, no bleeding/cough/nasal congestion/itchy throat/oral lesions/conjunctivitis. She has never had a reaction like this prior has never had an adverse reaction to any vaccine, does not have any allergies and only takes occasional TUMS over the counter for heartburn, all other medications as prescribed.  Patient has not had other illnesses, recently started cocktail for suspicion of non-pulmonary tuberculosis; per TB clinic: Patient had granulomas in abdominal lymph node- still awaiting TB results from lab, CXR was normal, has suspected abdominal TB, not Pulmonary TB.  Present with daughter who is asking about benadryl- instructed not to give since reaction is vascular not dermal, patent has no itching and patient is already dizzy- will exacerbate.  Vitals  Entered Date: 03/09/2021 12:18:34 Weight  :  66.68 kg / 147.00 lbs;  Height :  152cm / 59.75 in BMI :  28.95(Overweight);  BP(Left) :  127 / 59 mm Hg (Sitting/L arm) Pulse  :  93/min;   Temperature:  36.33 degrees C / 97.40 degrees F Temperature Status :  Tympanic Membrane;   Oxygen Saturation : 99%  BSA:  1.68 m squared  General(Visti) 1. General Appearance(Vist) : Well nourished body habitus, appropriately groomed, patient is in no acute distress., Moderately overweight body habitus, patient in no acute distress., Not in acute distress 2. Mental Status : Normal 3. Neuropsychiatric : Normal 4. Gait and Posture : Normal 5. Hydration : Normal 6. Speech and Voice : Normal 7. Cognition : Normal  8. Orientation : Normal   Eye(Visit) Additional Comments: scelera mildly injected- per patient this is her usual state  ENMT (Visit) 1. Nose(Visit) : Normal  Chest and Lungs (Visit) 1. Respiratory (Visit) : Normal 2. Chest and Lung Exam : Normal  3. Movements : Normal  4. Shape : Normal  Cardiovasculars (Visit) 1. CV(Visit) : Regular rhythm  Peripheral Vascular.  1. Lower Extremity : No edema - Bilateral   Neurological.  Additional Comments: intention tremor of hands  Integumentary Additional Comments: erythematous blanchable coalescing papules concentrated on upper arms, less diffuse on lower arms, lower torso and thighs warm at upper chest, back, arms  T50.Z95A-Adverse effect of other vaccines and biological substances, initial encounter