chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child received immunizations on 06/20/2005 at 1:00pm.  When awakened at 7AM, 06/21/2005, rash noted on trunk - close together, pimple-like.  Temperature 100 - given infant Tylenol.   Rash spread to face throughout day and slightly on extremities.  06/21/2005 - 06/22/2005 - Child more sleepy, no interruption in appetite.  Seen by Dr on 06/23/2005 - Rash nearly resolved.  Doctor felt rash may be from MMR injection or any other allergies.  Doctor did feel child should receive 2nd dose of MMR when appropriate.
warm to touch; itchy; redness (inj site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness (inj site)) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DENTAL PARAESTHESIA (non-serious), TOOTHACHE (non-serious), HYPOAESTHESIA TEETH (non-serious), outcome "recovered" and all described as "experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day".  Additional information: The patient reported that she experienced a tingling and numbness in the teeth that evolved to toothache that disappeared the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A red ring around the injection site appeared 1.5 weeks after getting the injection. It was not red at all the week after getting the injection. The red ring was slightly raised on the skin. It was not particularly painful. It went away in about 48 hours.
Unusual bruising occurred the day after the FLUAD shot was given. No pain. No side effects. Bruising down bicep muscle approx. 1 in lower than injection - About 2 inches wide. Bruising at site of injection also.
Slight headache and temp 99.2 deg F 24 hrs after administration. Hives started on 05/27/02 lasting several days. Seen 05/28, given Allegra with gradual improvement.
pt devel uncontrollable crying 48 hrs p/DTP/OPV/HIB given; pt had no fever, but seemed to lose/consciousness & stop breathing, temporarily (10-15mins); pt was taken to ER & is reported to be in good condition @ this time;
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Approximately 48 hours post vax, this child's face looked flushed, pink, swollen - like an intense sunburn however she wasn't exposed to the sun. She was also irritable. This resolved within 3 hours.
COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care.  Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine   HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER.  She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur.    IMPRESSION: Anaphylaxis Anxiety attack
Elevated blood pressure 171/101. Elevated heart rate 112. Elevated temperature chest pain, shortness of breath, arm pain, and rash.
Information has been received from a physician concerning a 73 year old female with no known allergies who on 21-JAN-2007 was vaccinated SC with a dose of Zostavax (lot#656412/1476F). Subsequently, the patient developed redness with a little bit of pink around the injection site about the size of a half dollar. The area was slightly hard and tender. No laboratory tests were performed and medical attention was not sought. As of 24-JAN-2007 the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 02/13/2007. Information has been received from a physician concerning a 73 year old female with no known allergies who on 20-JAN-2007 at 17:45 was vaccinated SC with a first dose of Zostavax (lot # 656412/1476F). Subsequently, in the evening on 20-JAN-2007, the patient developed redness with a little bit of pink around the injection site about the size of a half dollar. The area was slightly hard and tender. It was also reported that the site was warm tot ouch. The patient's adverse events lasted approximately 4 days. No laboratory tests were performed and medical attention was not sought. The patient recovered. Additional information has been requested.
Within 45 minutes of receiving the the Moderna injection I started with a headache and the beginning of hives. I took a Benadryl to stop the hives progression. I had to take antihistimes for several days.  The hives never popped up so the meds helped.  My head felt bruised and heated as if the blood was pumping around my skull.  The headaches are still intermittent 6 days later. I did not seek medical care.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
loss of his short term memory; rash, his skin is hard and breaky; itchy; it comes off like pieces of plastic; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated he received both Pfizer shots. On an unspecified date, the patient reported he was having loss of his short term memory. He had a rash, his skin was hard and breaky, it was itchy and it comes off like pieces of plastic (unspecified dates). He also had a fever for a while after the second shot, and he was not able to remember anything. He could remember all his past, from when he was 3 years old, but he could not remember if he was doing something. He stated he did not have a memory problem before. The outcome of the events were unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.
Itching, bad rash, headaches, leg cramp, blisters, stiff neck, muscle weakness, numbness (L) foot, pain (R) shoulder and (L) hip. I have wt. lost at least 20lb. Presently wt 110. 5ft and 8" tall. I do not look like myself. All summer long, I wore long sleeves. I was ashamed of my arms, so skinny, with scars, and wrinkles, I lost a lot of muscle tone, all over my body. From the shingle shot. I have never had Chicken Pox. I told my Dr. before I took the shot. So she could evaluate the situation. My Dr. really didn't pay attention to me on it. I see her on my visit in Dec, 2018. She saw the wt I lost and the scars on my arms.
I started my period three days after I got vaccinated. I do have a heavy period because of uterine fibroids but this time it was even heavier than usual.  Every hour, I had to change a blood-soaked overnight pad during the first night.  After one night and a day of bleeding, on the second night, I had a near faint experience and I collapsed on the bathroom floor with nausea, cold sweating, hands numbing, short of breath.  My husband called an ambulance and I was transported to ER.  ER gave me fluid and did a blood check and gave me a medicine to reduce bleeding.  I was discharged a few hours later.  I am still bleeding but the amount is less. I have never experienced this severe period till I experience near faint.
After receiving the vaccine, I had hives that appeared on my body about two weeks later. They appeared on my back mostly and spread out a little on my forehead and some of my arms. They went away after 24 hours, I took some Alka-Seltzer. I then saw the doctor who did a in office skin exam and determined it was hives. The hives still come and go and I take the over counter medication the doctor recommended.
Received the pneumonia shot in right arm. Arm is badly swollen in shot area, itching, painful to use, feeling a bit tired, redness.
Got really sick after; Aches and pains; severe chills; fever around 100.05 f; Terrible headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f) and HEADACHE (Terrible headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder, High cholesterol and Seizure.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue). On 09-Jan-2021, PYREXIA (fever around 100.05 f) had resolved. At the time of the report, VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 100.05 100.05 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am a 47 year old reservist who has rheumatoid arthritis, autoimmune disease. In April and May 1999, I received my first three Anthrax vaccinations. From lots (FAV038, FAV038, FAV041). That summer, June/July 1999, I started experiencing rashes (red blotches with little white bumps) on my toes/feet, knees and fingers/hands. These were unique experiences in my life. (I did have an outbreak of hives once when I was 5 years old about 3 minutes after receiving a shot of penicillin.) Unique in this since, sometimes the rashes would start after exercising, walking or riding my bike, but not always. Sometimes after showering, again not always. And sometimes if I was just sitting reading or watching TV and out of nowhere, with no apparent reason, the rashes would start. Most times the rashes would be intensely burning and itching, literally like being tortured. Sometimes I thought I was going to go out of my mind because it was so intense. It would usually fade away after a couple of hours. This continued like this, 3-4 times a week, and then started to fade away to once or twice a week, until October 1999, when I received the fourth shot. When I went in for the fourth shot, lot FAV044), in October 1999, I asked if the shots could be the cause of the rashes. I was assured, by the Med Tech at the clinic there is no medical evidence that the vaccines caused this to happen and received the fourth shot. The rashes became increasingly intense again and this lasted for about another year and a half. There was no report done. Eventually the rashes started to fade away and maybe happened once a month at most. On 10/1/01, I was activated due to 9/11 and on the 8th received a Td vaccination. By 10/15/01, the rashes had started again but also with swelling in my toes that became very painful. For the next few months, all my toes became involved and it moved to my knees and to my fingers/hands. In December 2001, I saw my PCP and in February 2002, he made an appointment for me to see a rheumatologist in March 2002. My rheumatologist first impression was early RA, as he noted in my record of care. It has not been two and half years I have suffered with this Rheumatoid arthritis and the military continues to deny that there is any connection between the vaccines and the RA. (OMIC) Follow-up: Diagnosed with Rheumatoid Arthritis (chronic condition - lifelong). Undergoing medical management for condition.
right arm was a bit sore by the injection spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm was a bit sore by the injection spot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (right arm was a bit sore by the injection spot). In February 2021, VACCINATION SITE PAIN (right arm was a bit sore by the injection spot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-379265, MOD-2021-378255 (Patient Link).
This case was reported by a physician via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 25th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician was reporting the case for himself. On the day of reporting, he felt achy and tired.
Trouble swallowing, expelling mucus, tongue swelling, shortness of breath.  Epi administered IM in right thigh. Patient sent via ambulance to  hopsital.
It started around March when I noticed that my blood pressure just kept going higher and higher. I don't know if its the vaccine or I suddenly became hypotensive. Its the only change I have had in terms of medication or vaccination. I went to the ER and they admitted me and did test, EKG. They decided to put me on medication. The first prescription didn't work because I was having a lot of adverse effects so they have prescribed me another medication to try. Also after the 1st vaccine my menstrual cycle was irregular and heavy and it got worse after the 2nd vaccination. I went for an ultrasound and they found that I had really small fibroids, which I have never had in my life.
Report number A0375263A describes arthritic type condition of joints in a male (age unspecified) who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings. The personal injury claims of April 2002 noted the injury sustained was arthritic type condition of joints, which occurred in June 2000. The claim classified this injury as a permanent injury. The claim denied that hospitalization or surgery were required for this injury. As of 19 July 2002, the outcome of the adverse event was unknown. The adverse event of arthritic type condition of joints is labeled per the USPI. The adverse event does not meet ICH serious criteria but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Little fever, redness, tenderness at the site, diarrhea the next day, some cough since. Patient had first PREVNAR 13 on 02/24/2017, should have received PPSV23.
Severe shoulder pain to sternum down to elbow. Whole upper arm swollen = fever x 12 hrs. Purpura = appeared x 24 hrs.
Local reaction, 2x2 cm of erythematous, tender, warm rash on R arm. Symptomatic treatment.
Two hours p vaccine developed chills. Achy headache, dizziness for two days. After that since then daily diffuse body pains, headaches, intermittent dizziness& nausea  intermittent chills, intermittent abdominal pain
Swelling of joints, rash, itch, swelling to lips.  Benadryl, epi-pen.
Client received vaccine at 6pm on 10-1-14. Client was found unresponsive on 10-3-14 at 4:15 AM. Client was pronounced dead at 4:39 AM.
Patient called pharmacy on 11/5/14 (6 weeks after vaccine administered). She had no visible injection site reaction, but said she is having severe, sharp pain at injection site, especially when reaching back or applying pressure to site. Relieved by ibuprofen, but she refused doctor visit.
Swollen eyelids; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swollen eyelids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Mar-2021, the patient experienced SWELLING OF EYELID (Swollen eyelids). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING OF EYELID (Swollen eyelids) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant Text: The patient received the first dose of the Moderna COVID-19 vaccine on 26 Mar 2021 and on 29 Mar 2021 the patient woke up with swollen eyelids, especially the one from the side of the vaccination. The swelling subsided on the same day but on 30 Mar 2021 morning, the eyelids were swollen again.   No Concomitant product use was reported.
Patient experienced a sore arm and tingling in his fingers and cramping in muscle. Symptoms began after receiving the vaccine and for 3-4 weeks.
Pregnant patient received vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus since October 2004 and Penicillin allergy. Concomitant products included INSULIN LISPRO (HUMALOG), ACETYLSALICYLIC ACID (ASPIRIN 81), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM SLEEPMELTS) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 27-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound foetal: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dry cough, heavy chest - extended monitoring - Hx of diabetes and asthma.
Inflammation , bruising on my left arm  and also  right legs , SOB , chest pressure  and pain ,  body aches and weakness  , headache and eye pain