chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-JAN-2017 the patient was vaccinated with VARIVAX (lot # M013068, expiration date 14-APR-2017, route and site of administration were not reported) 0.5 ml for prophylaxis. It was reported that the STERILE DILUENT was used to reconstitute VARIVAX. A "volume of 0.55ml of STERILE DILUENT was used to reconstitute and only 0.5ml was withdrawn from the VARIVAX vial post reconstitution and administered to the patient, not the entire contents". The deliverable volume of the STERILE DILUENT vial ranged from 0.62 mL to 0.83 mL with an average deliverable volume of 0.7 mL. Additional information is not expected because there was no consent for further contact.
5-1-04 mom noticed few pink raised bumps on child's back. Many more on 5-2-04 esp on face. Ion-grade fever 5-2-04. fever 102.5 on 5-3-04 without meds. Few spots noticed on neck/arm on 5-3-04. Around 50 spots total as of 5-3-04 and still increase in number. Still progressing.
Patient endorsed nausea, vomiting, loss of taste/smell, and cough 7 hours after vaccination.
About 1 hour after injection, while resting, I avoided as long as possible the recommended dose of NSAID for swelling, pain at injection site, other pains, reported with VAERS at the time of the vaccination #2.  I started to hear synthesizer type violins. I waited to listen, so i would be able to describe the sounds to someone. they seemed to be coming from inside my brain, behind my left ear and lower, to the left corner side of my brain (where there is a bump on the lower left corner of my skull). I worried that the sounds might be symptoms of brain damage. Unsure if they were pleasant sounding or demonic, but somewhat in harmony. Even disharmony can be pleasant. It wasn't a set of disturbing sounds. On social media, I think I posted "I hear violins", or after news, I might have posted "I hear violence."  So long ago I don't remember the post exactly.  There was discord (ant?) notes within the harmonies/disharmonies. All plaing long, straight tones, synthesizer-like. This lasted for about 5-15 minutes, maxiumum.  I continued reporting with VAERS, and I might have reported the sounds I heard with the survey system which I signed up to participate in after each vaccination. I also reported the typical, expected adverse symptoms.
Developed urticaria about 10 min. after FLUMIST. No n/o any food/medication allergies.
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She was not administered any concomitant medications. On 28-JUL-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX lot# M039453, expiration date 19-DEC-2017 (dose was not reported) for prevention of shingles. The vaccine was reconstituted with sterile diluent (DILUENT MRK) lot# M014921, expiration date 30-NOV-2018. On 29-JUL-2017, the patient began experiencing redness and itching at the injection site. The patient presented at pharmacy. There was no treatment given for the events. No laboratory diagnostic studies were performed. The outcome of redness and itching at the injection site was reported as not recovered at the time of report. The relatedness between redness and itching at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
I Received Moderna COVID vaccination 12-28-20. minimal SE's; received 2nd Moderna shot 1-25-21, minimal SE's; received Moderna booster 8-15-21, terrible aches and fatigue, lasting 24-36 hours, recovered fully by 3 days. On 1-8-22 awoke with fatigue and sore throat, home tested positive for COVID, confirmed positive at local testing center 1-10-22. Fatigue, muscle aches and pains, sore throat, mild cough, shortness of breath but normal O2   , all moderate symptoms lasting about one week. Reported to PCP, who recommended outpatient IV Remdesivir x3 days (prior cancer treatment, considered possibly Immunocompromised). Mild symptoms persisted x one month. Recovered uneventfully.
Joint soreness in my right arm days after the injection. Then 4 days later my lymph nodes in my neck swelled so large that it was hard to swallow and made my joints in my jaw hurt. Followed by fever and chills. Neck is still a little swollen
Beginning on October 9th, I?ve experienced lots of skin itching followed by dermatographia. Antihistamines have relieved the intense itching sensations, but the dermatographia persists whenever anything touches my skin. On October 12th, I started experiencing swelling and pain in my ankle joints.
Developed chills, feverish, joint aches, body aches, headache and then this morning woke up tp dizziness and disorientation
Given nasal mist instead of injection due to asthma. No increased wheezing per grandmother.
1st injection (1/7/21)-12 hours later ( approx 3 a.m.) felt achy, fever up to 102.7degrees, sore arm, fatigue and headache. Took tylenol several time through the day and fever resolved approx 7pm on 1/8/21.  Approx 11:00pm that day I woke up dizzy and felt chest heaviness, but went back to sleep.  Woke up again after midnight and sat up in bed and felt like I was falling out of the bed (extremely dizzy) and decided to check my oxygen level due to me having prn shortness of breath since contacting covid in July 2020 and noticed that my heart rate was 186 bpm.  Went to ER and MD was told that I had a covid shot the she wasn't sure if that what caused the SVT and could not tell me if I should or shouldn't take injection #2. Injection #2-(1/29/21) 4 hours after taking this injection started with low grade temp, sore arm and achy all over and noticed my heartrate was in the 120's.  Woke up next morning temp was 103.0.  Took tylenol troughout day and that day.  Heart rate was in the upper 150's.  I did not go to the ER.  The next day heart rate continues 140-150.
I received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am  on April 6th, I woke up hot and itching.  I had a under the skin rash on my arms and legs with little pin prick spots my tongue was  tingling.  I took Benadryl.  It was better in the morning but still visable and tongue was tingling.  I took more Benadryl around lunch time.
Arthritis, body aches, swelling in joints, felt groggy or in a fog.
Mild rash on bilateral upper extremities, non-pruritic rash. No associated symptoms or shortness of breath.
I experienced fatigue, muscular pain, and exhaustion (laid down took a couple of Advil).  The reaction was intense and I felt the symptoms for a few days.
The customer reported a patient received an MMRII vaccine that was reconstituted with expired STERILE DILUENT.; The customer reported a patient received an MMRII vaccine that was reconstituted with expired STERILE DILUENT.; No other AE reported.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 12-NOV-2020, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as prophylaxis (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), which was reconstituted (medication dilution) with 1 dose of an expired sterile diluent (MERCK STERILE DILUENT) (product preparation issue) (formulation, strength, frequency and route of administration were not reported; lot number S018816, which has been verified to be valid, expiration date reported and validated as 14-SEP-2020). The reporter stated that, the product had not had any temperature excursions. No additional adverse events were reported.
Lightheaded, mild nausea, diarrhea, chills, sweats, temp 38.3 on 3/11.  On 3/11/09 at 11:30 AM 11cm x 6 cm region of induration, erythema and warmth over left tricep, extremely tender.
PATIENT STATES RED, PAINFUL AND SLIGHTLY WARM RASH FOR 72 HOURS. RASH IS 6 INCH BY 3 INCH SIZE, ABOUT 3 INCHES LOWER THEN VACCINE AREA (RASH DOES NOT INCORPORATE EITHER OF THE VACCINE LOCATIONS). AREA IS NOT ITCHY BUT IT HAS BEEN HARD TO THE TOUCH FOR 24-48 HOURS.  COMPLAINS OF FEVERISH SYMPTOMS AND FULL BODY ACHES THAT CAME ON 12 HOURS AFTER THE VACCINE AND LASTED FOR LESS THEN 24 HOURS.
Low grade fever; Had no taste or smell; Did not feel great; Headache; Body Aches; Fever of 100; Chills; Run down like the flu; Congestion; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 09-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100) and CHILLS (Chills). On 10-Jul-2021, the patient experienced FEELING ABNORMAL (Did not feel great). On 13-Jul-2021, the patient experienced ANOSMIA (Had no taste or smell). On 19-Jul-2021, the patient experienced PYREXIA (Low grade fever). On 12-Jul-2021, CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and PYREXIA (Fever of 100) and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-260133 (Patient Link).
This spontaneous report was received from a healthcare worker regarding her daughter of unknown age. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck). It is unclear whether the patient received one or two doses of VARIVAX (Merck) (lot#, expiry not reported). On an unknown date, the patient was diagnosed with chickenpox after receiving VARIVAX. The outcome of chickenpox was unknown. Additional information has been requested.
Considerable pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 05May2021 (Lot number: not reported) as second dose, single for covid-19 immunisation. Patient previously had his first dose of BNT162B2 on 14Apr2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt considerable pain on an unspecified date in May2021, a few weeks after he got second dose of the vaccine. The patient stated he was feeling better now. The outcome of event was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
noc of 17AUG92 had extreme fatigue, next morning fatigue continued, had 2 sm & 1 large sore on lower lip; cont 19AUG92 had severe h/a also on one in family w/similar sx;
6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray and bloodwork completed. 6/28/21: Seen by NP for weight loss. Ongoing issue prior to vaccine r/t poor appetite 7/1/21: Incident of hypoxia that required increase in 02, SOB, and lethargy. Sent to the hospital. Guest did end up passing at this hospital
This spontaneous report was received from medical assistant and nurse via a company representative and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with expired dose of MMR II lot # J009382, expiration date 08-AUG-2015 (dose, route of administration and anatomical location were not reported). No symptoms were reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 at 13:00 as dose 1, single (Lot number: EH9899), in left arm and on 09Jan2021 at 18:15 as dose 2, single (Lot number: EJ1686) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: Other medication in 2weeks No antiviral details product COVID 19 Treatment, brand Paxlovid, treatment start date 11May2022, treatment stop date 16May2022, indication Treatment of COVID-19, administrator route Oral.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Employee received Fluzone vaccine 0.1 cc intradermally (L) forearm; redness developed at injection site 1-2cm in diameter; tenderness to touch; resolved within 3-5 days; 7mm pink color - no  tenderness on 2-27-08.
Skin eruptions right side of body : above right breast, right under and over-arm, rightside  back, round spot on vertebrae approx T5. SHINGLES confirmed by dermatologist MD. Mild case (maybe because already taking for L-Lysine), mild itching, occasional pain, all easily bearable Patient's Treatment : essential Lavender oil and Tea Tree oil   (Did Not fill MD's prescription for an anti-viral) All blisters burst and on way to recovery before 2nd Covid vaccine shot March 26, 2021 After 2nd shot, skin on right side of body but especially down front midline,  very sensitive to touch. No eruptions. Bearable.
1040 Pt was sitting in the post vaccine area and was seen holding her throat having some difficulty swallowing. I approached her and she confirmed having some tightness in her throat with some difficulty swallowing.  She denied any SOB, no tingling of lips or swelling of tongue, no rash or hives. VS at 1040 were 142/84, 94 and 99%, skins W/D.  911 was called, and medication administration was held at that time without any other symptoms and pt wanted to wait as well on having any other medications administered at that time.  Pt was advised to alert us of any further symptoms.  Constant monitoring was done while waiting for EMS.  Pt was taken off of an antibiotic last week with PCN in it and while experiencing some mild symptoms.  Pt was on a 30min hold post having the Pfizer vaccine to the left deltoid due to having allergies to PCN.  It was approx. 12 minutes after her vaccine when the symptoms started. Her second set of VS at 1049 were 140/80, 78, and 99%.  No change in symptoms, pt remains calm without any SOB or hives. At 1056 pt states that it is getting easier to swallow. AMR on scene to evaluate.  Pt had no further symptoms and continued to feel better. Pt signed out AMA with AMR unit 461.  Pt was advised to call 911 back if any further symptoms arise.
My arms swelled up down to my fingers; it swelled up really really bad; It was hurting just a little bit; I couldn't take my rings off my fingers; Headache; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EL9262) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: 2019 (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Blood pressure " (unspecified if ongoing); "compromised immune system" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; CLONAZEPAM taken for anxiety; METOPROLOL taken for blood pressure abnormal; PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "My arms swelled up down to my fingers; it swelled up really really bad"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was hurting just a little bit; I couldn't take my rings off my fingers"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site pain". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, headache, vaccination site pain.  Additional information: The patient had the Pfizer vaccine a couple of days ago and I had a very bad reaction to it. When he got home arms were hurting just a little bit. It woke me up 3 in the morning swollen and paining and something terrible and all yesterday it was swollen so he called his doctor and he told him to take Benadryl. His arm was swollen so bad until he couldn't take his rings off his fingers. So, it was not as bad today it was still swollen, it was not as bad today and he don't remember reading swelling as one of the side effects, but it was very painful, it was swelled up he couldn't get comfortable, it just hurt bad until it brought me to tears. He still has some swelling in my left arm where they administered the vaccine and still have pain. They said some pain will occur at the injection site and he had the headache. The patient stated event date as 10Mar2021 (Not clarified).  No follow-up attempts are possible. No further information is expected.
Discovered 17-year old patient received JANSSEN COVID-19 vaccine, which is not currently indicated for age range on 07-06-2021. Unknown if patient had any adverse effects.
I was diagnosed with Hypertension in August of 2021. I think it had been creeping up for a while. The problem was diagnosed on a regular visit. I had experiencing tiredness during the early summer but the air quality was poor. I had not had my blood pressure checked in a while.
Dose #1 (2019) DTaP Infanrix:  Child began experiencing sudden reaction and symptoms of Erythema in Face - More expressed in Left Cheek - Pediatrician on call explained it looked like "Slapped Cheek Syndrome".  Reaction lasted a few hours.  No treatment administered.  Dose #2 (2020) DTaP Infanrix:  DTaP Infanrix Vaccine administered during Pediatrician appointment on 1/10/2020 at approximately 4:00PM.  Friday night child woke up at 12:45AM (1/11/2020) complaining that "It hurts inside".  Child was limping and had a stiff walk with strong difficulty walking.  Parents (we) had to pick child up and carry child back to bed.  We stayed with child through the night.  In the morning around 7:00AM child had the same complaint and behavior.  After about 30 minutes child slowly started walking normally.  The following morning (1/12/2020) child woke up with a red rash within a 2-inch radius of the vaccination site - left thigh.  We called the pediatrician on-shift and the doctor explained that it was a strong immune response and that it is not common, but it is not uncommon, and that he had seen it other times.  He mentioned it would likely resolve within the week and gave us some suggestions for area treatment.  The rash progressed throughout the day with increased redness, swelling, and covered most of child's left thigh.  The impacted area was approximately 4 by 3 inches, which we marked with a sharpie to monitor spreading.  After child's bath we applied a thick layer of over-the-counter Cortizone overnight.  This morning (1/13/2020) the symptoms had noticeably improved but not resolved.  We have pictures of the reaction and progression.
Patient felt dizzy immediately after the shot was given.  She said she was going to pass out, and did for about 10 seconds.  She was sitting up in a chair during this time, with her mom holding her up.  She came to, the about 20 seconds later, she passed out again for another 10 seconds.  She came to, and was given some water to drink, but 20 seconds after that she threw up the water.  I took her blood pressure, and it was 60/40, with a pulse of 60.  She was very pale.  After resting in the chair and taking deep breaths, her color returned and she felt much better.  she also said her vision wasn't blurry anymore.  Ten minutes later, she left with her mom, feeling ok.  She was very anxious about getting the shot, and told me she had passed out in the pass after giving blood.
Information has been received from a lawyer regarding a case in litigation concerning a 69 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2011, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 02-MAR-2017, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
MOP states 3hrs after getting the vaccinations pt states having a rash on bilateral thighs with hives on his chest. MOP denies pt having any other symptoms, fevers or SOB. MOP denies any treatment. MOP states symptoms lasted for 36hrs.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in a normal birth of a full-term infant with no defects.  The subject had not been using contraception prior to becoming pregnant.   On 7 September 2011 at 10:45 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, left arm), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 28 weeks gestation at the time of vaccination.  Date of last menstrual period was 22 February 2011 and estimated delivery date was 29 November 2011.  Prenatal testing including ultrasounds performed on 25 April 2011 and 12 July 2011, and maternal serum alpha-fetoprotein on 08 June 2011 had revealed no evidence of a defect.  Upon internal review done on 17th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 25 April 2011 and 12 July 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 08 June 2011 revealed no evidence of a defect.
Severe pain at injection site. Fever. Aches. Cough. Fatigue.