chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of vaccination site swelling (swelling of arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 014MM20A and 0256C1) for COVID-19 immunization. Concurrent medical conditions included immunocompromised and Myasthenia gravis. On Feb 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 intramuscular; 1 dosage form. On Oct 20, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site swelling (swelling of arm). At the time of the report, vaccination site swelling (swelling of arm) resolved. No concomitant medication or treatment information provided. Reportedly, after 1st and 2nd dose for about a week and a half the patient reported swelling of arm after receiving each dose, which then resolved. The patient on the phone reports no reaction after 3rd dose, which is why she is questioning the dose this was. Also stated that unsure if the wife received a Moderna booster 3rd dose for being immunocompromised with myasthenia gravis. This case linked to MOD-2021-361631 (patient link).
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (fully vaccination consumer, tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. Company comment: This case concerns an 88-year-old male patient, who developed the unexpected event of COVID-19, about 5 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Sender's Comments: This case concerns an 88-year-old male patient, who developed the unexpected event of COVID-19, about 5 months after the second dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Waves of extreme, intermittent vertigo and dizziness. Presented 2 weeks from second shot. Still suffering.
About 1 hour after the vaccines, my 4 month old son suddenly lost all color, went limp, and passed out. This lasted several seconds before I was able to nudge him to become alert again. He remained very pale for a couple days afterwards.
Big red patch around injection site, not raised, itching. Recommended patient take benadryl capsules and use ice pack to help with redness and itching. Since patient also have appointment next day for health clinic (unrelated), also recommended she show to health care provider.
pt recv vax; devel arthralgia in rt foot & rt knee;myalgia in all joints;exp tiredness, weakness, lack of appetite &  visual weakness, lasted x 2 days;
THROBBING PAIN IN RIGHT SHOULDER; This spontaneous report received from a patient concerned a 92 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in shoulder, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18040Z0, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced throbbing pain in right shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from throbbing pain in right shoulder. This report was non-serious.
Fever (101 degrees), diffuse body aches/stiffness with onset of about 3 hours following vaccine administration.
Pt feels pain at the injection site, slight swelling. Her Temp was 98 F yesterday and today 100.1F. Pt has had chills, fatigue and slight HA.
my eyes were swollen then following day after my second shot.  my right eye was nearly swollen shut.  It took 2 full days for the swelling to get close to normal.  I took benadryl during that time.  On my first shot I did have a red, itchy, hot spot at the site of injection but no other symptoms.
Patient states tingling in his hands. VS stable. No signs of respiratory distress, N/V. Water was offered. Patient feels better!
CDC reports: 4 yo child developed a fever to 101.8 & local rxn following DTP/OPV/MMR immunization. 4MAY90 pt started on Amoxicillin, depressed typanogram R > L, otitis media, brother who did not have MMR also had a virus.
Patient stated that she developed swelling and that her veins started to protrude and she felt a slight pain in her arms.
soft swelling over rt clavicle proximal to rt shoulder, tender to touch, discovered while dressing 12MAY93; pt describes swelling as dec today 13MAY93;
palpitations, chest pain,  high BP, fatigue, increased allergic response, burning eyes/swelling, increased blurred vision  eczema  exacerbation, worsening Dystonia (especially oromandibular) numbness/tingling lower legs/feet
A patient experienced upper respiratory infection after receiving FluMist in 17 Nov 2005.  The upper respiratory infection has persisted for about six days at the time of report.  Further information has been requested.  The clinical outcome is unknown.  The reporter causality is not provided.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 04-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K016153, expiration date 24-SEP-2016, dose unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Vax'd 2/7 w/smallpox. Left foot started itching and swelling 2/8 evening. Swelling decreased 2/9 evening. Right hand had similar Rx w/itching and swelling on 2/10, went away that evening. Lower back swelled late that same night, 2/11 morning went away. 2/11 afternoon left hand itching and swelling, and present 'til that evening.
Later in day arm pain Next day fatigue, headache, dizziness, constipation, arm pain, fever, sore throat It?s been 2 days and slightly better but still there. Couldn?t work for last two days.
Patient states in the afternoon, after getting home from office and then lunch she felt tired so she napped. She awoke to her left arm being swollen from shoulder to about one inch above her elbow, hard, itchy and painful. She called our service at 6:34pm. She was advised to go to urgent care. Her daughter took her at 8:30pm to hospital ER where she was given BENADRYL and steroids. Swelling appeared to be decreasing and patient was discharged at approx. 2am on 11/8/17.
The following information was received via VAERS download on 20 Feb 2012. A 20-year old male received IXIARO (batch-no. JEV10656F [incorrect batch number; most likely JEV10G56F]) i.m. on 05 Oct 2011. Concomitant medication included smallpox vaccination on an unspecified date. On 13 Nov 2011 vaccinee developed lump in axilla, chest pain, photophobia, vomiting, nausea, headache. Lab data indicated encephalitis or encephalomyelitis due to smallpox vaccine. In addition, the database included pneumothorax as an adverse event term. Vaccinee was hospitalized for five days and recovered.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: swelling and pain at injection site-Severe, Additional Details: pain and swelling  at the injection siteweakness
I contracted COVID-19 on 04/20/2022 with symptoms of nausea, cough, extreme fatigue, fever of 102.5 at highest point, congestion, mild sore throat, headache, myalgia, abdominal pain, and chest tightness, and chills. I had an e-visit where I was prescribed an albuterol inhaler, benzonatate, and told to take Tylenol. I was ill for 15 days before my symptoms began to resolve. I still have an intermittent lingering cough.
PROQUAD administration in adult; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 22-OCT-2020, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) lot # S035103, expiration date 03-MAY-2021, for prophylaxis (route of administration and anatomical site of vaccination were not reported).
Pt recvd vax & 1/2 hrs later exp dizziness, lightheadedness, strange taste in mouth & h/a;
This spontaneous case reported by a consumer, describes the occurrence of tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The patient's past medical history included COVID-19 on Apr 2, 2021. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient experienced tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache). On May 6, 2021, tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) resolved. Diagnostic results: On Apr 2, 2021, SARS-CoV-2 test: Positive. On Apr 29, 2021, body temperature: 102ºF (high) fever. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Dizziness FATIGUE; SWOLLEN CERVICAL LYMPHNODES; JOINT AND MUSCLE PAIN; CHILLS; SWEATS; SITE TENDERNESS; PSORIASIS FLARE Narrative:  EMPLOYEE STATES: SHE HAS AN AUTO-IMMUNE DISORDER (MIXED CONNECTIVE TISSUE DISEASE- SX AND FLARE UP DAY 0: DIZZINESS, FATIGUE; SWELLING CERVICAL LYMPH NODES DAY 1: EXTREME JOINT AND MUSCLE PAIN; SITE SWELLING/TENDERNESS; CHILLS/SWEATS; DRY MOUTH AND DRY EYES (SJOGRENS FLARE UP); CANKER SORES (AUTO-IMMUNE), FACIAL BREAKOUTS, LOSS OF APPETITE, PSORIASIS FLARE SX LASTED 5 DAYS  Other Relevant Histiry:
myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient in her 30's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: Patient was asthmatic. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The patient received the first dose of COVID vaccine (did not specifically state it was Pfizer's) and developed myocarditis so did not receive second dose. Event took place after use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported event myocarditis and bnt162b2 cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt reports raised, fire bump red rash that began on trunk - spread to legs - on 11/22; went to urgent care center 11/25 2 hours itching and no improvement with topical antihistamine cream; TX with steroid taper - trunk rash resolved - now on back and remains on legs - no other symptoms reported.
Excessive coughing, some wheezing, headaches, bodyaches, earache, low-grade fever, random sneezing, fatigue, feeling nauseated but no vomiting.  The onset of symptoms started 10/9/2021, after receiving booster vaccine on 10/8/2021.  Since that time all symptoms have gotten worse.  I first went to a clinic on 10/14 at roughly 745pm.  Since I had just received the vaccine they only gave me cough syrup and said symptoms should subside soon.  I had a telephone consult with a doctor on 10/28 to tell her of continued symptoms after Booster shot from 10/8/2021.  I had been taking over the counter medication, and the cough syrup previously prescribed with no relief.  She has since provided me with an inhaler (albuterol), a medrol dosepack, Amoxicillin 875, Guaifenesin, and  Benzonatate cough pearls.  Doctor will see me again for tests if no  improvement occurs within the next ten days.
When patient returned for 2nd set of immunizations on 07/22/04 Mom said child had a reaction after the 1st set on 05/20/04.  She said at midnight the child felt warm (did not check temp) and vomited. Mom stated "He seemed to be unaware of his surroundings and starred...it seemed like he couldn't focus"  "This lasted about 15 minutes".  Mom says the child seemed fine by morning.  DTaP was deferred that day and child was referred back to his PMD for evaluation.
Redness, itching, burning.  50mg Benadryl PO.   Symptoms decreased with tx
Feet broke out in Hives several hours after receiving Flu shot on 10/26 feet very itchy red and covered in welts per mom's description, mom gave bath and treated with BENADRYL.
Moderna Vaccine Reaction  D: Patient came in for her second Moderna vaccine dose.  Patient reports first dosed caused hives all over approximately 60 minutes after receiving vaccine.  They went away 1-2 hours after they appeared without any medication.  Patient was advised by her primary care provider to receive her second dose.  Patient received second dose today and was advised to wait 30 minutes.  After 30 minutes patient began to experience itching on her face and neck.  No visible hives. Denied any mouth swelling or throat swelling.    A: Patient received 25mg of oral diphenhydramine and advised to wait an additional 30 minutes.    R: Patient reported no increase in symptoms and felt okay to leave.  Patient advised to call 911 if she develops any worsening symptoms like facial swelling, throat closing, difficulty breathing.  Patient agreed.
Contractor presented for Dose #2 Of Covid Vaccination. While in observation area, contractor reported itching over her body. (740am)  Benadryl 50 mg IM given at 0744. VS 0748 BP 137/87 HR 65 02Sat 100% RA; VS 0800 136/90 HR 60 02sat 100% RA; VS 0822 BP 136/98 HR 64; Symptoms resolved 0820.  Contractor educated not to drive under the influence of medications.  She will report to her office to sleep/make arrangements for a ride home.   0823- discharged from observation
slight pain in their arm; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer (Patient) reported that she received Pfizer Covid-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration 18Mar2021 at as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. Patient reported that she, her mother, and her husband got the first dose last Thursday. Patient would like to know the timeframe of getting the second dose and said she wishes to get her second dose later (22 days or 25 days) so that she can take care of her 90-year-old mother in case she gets any side effects. Reporter stated that they have experienced slight pain in their arm after the first dose. The outcome of the event was unknown.  Follow-up (24Mar2021): This is a follow-up spontaneous report from a contactable consumer. No new information was added in the follow-up.  -Attempted to cold transfer to service unit due to long waiting time, the caller refused -Created and submit AE form:
Back in January 23,2022. It felt like a really bad cold, with headache and muscle ache. I was nauseous and had real bad diarrhea. It was also non-stop coughing. The first start of coughing was hurting my throat really bad. I took Robitussin DM cough syrup. I have not really gotten over the symptoms. I am having real bad coughing spells. My fatigue is better than others some days. I am too tired to walk. I don't feel much better at the time. I am having frequent headaches and I have never had them before. I just now have gotten over the stomach problems. I think my asthma has gotten much worse. I saw my PCP and she prescribed me some medicine for my asthma, I am constantly out of breath, I was energetic before COVID. I can not function as I used to, I feel to tired to do my normal activities. I have constant shortness of breath.
Red raised warm wheel approximately 1.5" diameter at injection site  assessed 7/13/19 in office 0915 with complaint of tightness, itching, tingling L upper arm . Employee reported more redness in surrounding tissue previous night.
This is a 86-year-old male with past medical history of hypertension, hyperlipidemia, type 2 diabetes, peripheral vascular disease status post left forefoot amputation, dementia, anxiety, depression, BPH, myelodysplastic syndrome, diabetic neuropathy. He came to the hospital with a chief complaint of altered mental status. Patient unable to provide detailed history due to metabolic encephalopathy. Currently no family members at the bedside. Was reported that the patient has been positive for COVID-19 and under isolation.    Tested positive on 8/30/2021
Came to Vaccine clinic feeling unwell with headache and lightheadness.  After the vaccine, he was c/o feeling unwell with 9/10 HA, lightheadedness, dizziness.  He noted that his HA/symptoms had been present for 2-3 days prior and he had been taking ASA without relief.  He was HD stable but diaphoretic.  Clinic staff administered glucose gel without effect after he stated that he was diabetic and had only eaten a banana all day.  Because he continued to report feeling unwell and was ill appearing, EMS was called and the patient was taken to local ER.  At local ER he was told his blood pressures were high, and he was given something via IV (unsure what). He reported then that he did not take his blood pressure medication on the date of the vaccine administration because the timing conflicted with the COVID vaccine. He was discharged from ED after four hours and PCP follow up arranged within the week.
Transverse Myelitis (idiopathic); This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 24Dec2020, outcome "unknown", described as "Transverse Myelitis (idiopathic)". The patient underwent the following laboratory tests and procedures: CSF test: Unknown result; Magnetic resonance imaging head: Unknown result; Magnetic resonance imaging spinal: transverse myelitis. Therapeutic measures were taken as a result of myelitis transverse.  Clinical course: Tingling in both hands following 1st dose. After 2nd dose, paresthesias in feet, weakness in left arm and both legs. Difficulty climbing ladder and fell in his home. Underwent L3-4 fusion, but paresthesia and weakness worsened. Uncontrolled twitching in both thighs and loss of function of left hand. Improved on corticosteroid therapy.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Transverse myelitis and the use of suspect product BNT162b2  cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Pt experienced a large red, raised area that was warm to the touch on the right upper thigh. No pain, no itching. Pt was treated with Benadryl, cool compresses.
Low grade temp 99 - 100.1° off & on for 2 days after vac. Swollen, red, warm-to-touch, soreness right upper arm for 2 days post vac.  Mild body & head aches for 24 hrs.  Occasional  mild chills.  Tired for 2 days after vac.  No treatment except rest.
Episodes of whole body shaking, one minute times two; one day apart. 2nd episode one day later.
Had vaccine on 7/29/18. Side effects of headache have persisted along with terrible aggravation of my FMG. Had renal panel 7/29/18. My creatinine went up to 1.3 and EGFR dropped from 60 to 40. Often feel a sleepiness I cannot explain. I am not diabetic, no HTN, no prior renal issues. Do not take any meds to explain changes.
Temp 102.4, Delirium. Severe myalgia. Moderate headache. Resolved after 18 hours.
This was the Pfizer booster. First two injections were in December 2020 and January 2021 respectively. The patient is a healthcare provider with frequent exposure to COVID-19 inpatients, thus qualifying for the booster.  Event was hives within 5 minutes of booster injection. Three hives: medial left elbow, right lower leg, right 4 toe. All resolved within two hours with Benadryl, taken immediately after first hive developed. Only prior reaction was significant left axillary lymphadenopathy following Pfizer #2 in January.
pt recvd vax & 7 days p/vax pt exp lt heel pain (wheelchair bound) & spondyloathropathy; pt was seen by MD;
Extreme fatigue, leading to blood work which discovered extremely elevated levels of liver enyzmes. Following Liver Biopsy on 5/12/21, I was diagnosed with autoimmune hepatitis.
That evening  he called me and told me his groin area was hurting and I went over to his house. He said he was having a hard time standing up. His groin and down his leg. He never had complained about it before. I took him to ER Hospital and they checked him out and verbally talked to him. The doctor told him to take Tylenol and told him to go home. He had that pain for about two hours.
pt seen approx 20 mins p/vax given was pale, lethargic, floppy, did not react to verbal cues, then to touching or shaking of car seat; very lethargic & floppy; pts breathing was shallow & irr; cried when rt leg touched;
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
A nurse opened the vial of Pfizer and gave the dose of 0.3 ml IM left deltoid without the diluent.  This was on 08/31/2021.  The patient states some soreness to arm and being tired.  No other side effects noted.  She stayed at the facility to work on some homework and was here up to 2 hours and no other effects noted.