chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; swelling; big reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SWELLING (swelling) and VACCINATION COMPLICATION (big reaction) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PRURITUS (itching), SWELLING (swelling) and VACCINATION COMPLICATION (big reaction). At the time of the report, PRURITUS (itching) and SWELLING (swelling) had resolved and VACCINATION COMPLICATION (big reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.         No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-229580 (Patient Link).
I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got a real bad headache, was very dizzy and felt very hot all inside my body. I reported  it to the nurse and she told me it was a normal reaction to the vaccine and to wait a little longer than the 15 minutes to see if it would go away. She gave me water and I did fell better and we left medical center. At around 5:30 pm that same day I started to get cold chills and body aches especially on my right side. my lower back and my right hip were hurting a lot and I was having trouble walking.at around 8:00 pm  my husband notice my right foot was very swollen and I notice by breast, my arm and hand, my underarm and leg were extremely swollen and painful. I did take a Tylenol because that is what they told me to take. I was freezing cold by the time I went to bed during the night I was sweating a lot. As of that day my symptoms were:      Swelling on my right side      Body aches, Headaches      Fever      Difficulty breathing/Shortness of Breath      Rapid heart rate ranging from 100-125 w/o doing anything      My neck and throat were very swollen around my thyroid area      Blurring vision      Chills and hot flashes       Fatigue/Malaise      Big round red welt around my injection site about 4 inches wide and hot to the touch I finally called medical center on 2/18/21 because I still had right leg, hip pain and swelling. I had a tele-med appointment with one of their doctors and she told me I had to first get a Covid-19 test to see if I didn't have Covid. Which the test did come out negative. She also told me that maybe the vaccine triggered something in my body that was causing all the swelling. I do have an appointment for chest, hip spine x-ray and lab work for 3/22/21. I still have the hip pain but not as bad. The person who gave me my Covid test results said I should report my symptoms.
3 hrs after shot (pneumonia), I developed severe pain in upper arm, sweating and faintness, severe pain, unable to raise arm for 2 days! Still sore!
Exactly 24 hours after receiving the vaccine, I began to develop a rash that turned into hives that were all over my body. My skin had a swollen appearance and became both itchy and burning. Within an hour after this rash started I fainted, immediately got back up, and faint right after. I was out for 2 minutes on the second faint. I vomited nearly 5 times an extreme amount. I had a fever, chills, and was disoriented. My blood O2 levels were in the 30's the entire time and my heart rate stayed between 95-110.   All of these symptoms lasted from around 5:00 pm to 9:30 pm   I took anti histamine immediately after the rash start and still have the symptoms above.
Rash, Swelling, fatigue, mild fever (99.0 farenheit)
Initial information received on 09/Oct/2006 from a consumer (the patient). An 18-year-old female patient received a dose of Menactra, lot number U1575AA, administered intra-muscularly in the left arm on 26/May/2006. On 27/May/2006, within 24 hours of vaccination, the patient developed a large red "bull's eye" area at the injection site. The patient was seen in an emergency room and treated with unspecified antibiotics and ice packs. The patient also reported that she was unable to eat dairy products and had diarrhea and nausea. The patient had no significant past medical history and no illnesses at the time of vaccination. She received the vaccine as a requirement for college. The injection site reaction resolved a month after onset. At the time of this report, the patient stated that she was still unable to eat diary products and the nausea and diarrhea continues. Follow-up information received from another company (reference number 1-81033439) on 13/Oct/2006. The information in this follow-up report was provided to the other company by the patient, and the case is not medically confirmed. The patient reported that two days post-immunization, on 28/May/2006 (previously reported as 27/May/2006), she developed a "bull's eye" circle at the injection site, which was also warm to touch. She went to the emergency room and was given antibiotics, but was not admitted. After this instance (exact date not reported), the patient "became lactose intolerant and cannot tolerate any diary products". No additional information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: PAA156051), in right arm, on 30Mar2021 as dose 2, single (Lot number: ER8272), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive; (23Jun2022) Negative; (25Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
tested positive COVID-19; tested positive COVID-19; This is a spontaneous report from a contactable healthcare professional, reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the COVID-19 vaccine on 28Dec2020, 9 days later tested positive COVID-19. She requested information on the recommendations for getting her second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on Jan2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Comirnaty's effectiveness is documented after 7 days from the second dose
fever between 104-105-felt warm all evening 6-8hrs noc of vax-had jerky spells-shook violently for about 10seconds-couple of times every 1/2hr;attempted to give APAP-did not take liquids well;
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
About one month after receiving my 2nd Pfizer dose I developed shingles.  I had chicken pox at age 6 and am 39 now.
Patient got her shot on 09/16/2017 for FLUAD and PREVNAR 13. She came on 09/23/2017 and stated she had a reaction . Her tongue swelled and her hip area became swollen  and achy too. She said she took Benadryl and she felt better and didn't go to the hospital.
Patient reported a hive-like rash to arms 1 hour after receiving 2nd Guardasil Vaccine on 09.15.09.  Rash lasted 10 minutes & resolved without treatment
Shot was in left arm. On 10/20 I woke up with large swelling in left axilla, and minor swelling in right axilla.  This was the only symptom.
woke with massive headache and left arm hurt so bad I could not lift it.  My whole body hurt.  I spent the day in bed with a cold cloth on my forehead. I only the flu once and this was worse.  I had no energy and just hurt all over. I have never had any problem with flu shots but this one gave me a run for my money.  I feel better today just a mild headache.
Within a few minutes of receiving my first dose of the Moderna Vaccine, my lips began to tingle; within 45 minutes my entire face was tingling and within one hour my upper lip had started to swell.  I took 2 Benedryl fast acting capsules and was fine within one hour.
hives on back, neck, arms; itching at injection site; bumps on back, neck and arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on back, neck, arms), INJECTION SITE PRURITUS (itching at injection site) and RASH (bumps on back, neck and arms) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced URTICARIA (hives on back, neck, arms), INJECTION SITE PRURITUS (itching at injection site) and RASH (bumps on back, neck and arms). At the time of the report, URTICARIA (hives on back, neck, arms) and INJECTION SITE PRURITUS (itching at injection site) outcome was unknown and RASH (bumps on back, neck and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information include alcohol and salve on it.   This case was linked to MOD-2021-101475 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event Rash and Treatment information was updated.
Patient Received Hep B dose #2 on 10/26/17. She had dose #1 on 9/20/17 with no adverse reaction.  she sent agency an email on 11/3/17 stating she was having side effects that were "most notable 10/30-11/2" and is now starting to feel better. Her symptoms included dizziness, light headed when getting up from lying or seated position suddenly, headache, itching of hands and feet, runny nose, back pain and stiffness in neck and shoulder. She described it as "off balance, feeling hung over".  She also had numbness on bottoms of feet and described having to hold onto the bedside table for fear of falling. Staff responded to her email that these were normal side effects. Followed up with patient on 1/12/18 and she states she is still experiencing slight dizziness, lightheaded when getting out of bed/off balance. All other symptoms are gone except back stiffness and stated she has been seeing a chiropractor for that since before vaccination. She has not sought medical treatment for these ongoing symptoms yet, but has an appointment scheduled for 3/1/18 with her PCP.
This is a spontaneous report from a non-contactable consumer. A patient of unspecified age, ethnicity, and gender received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date (about 5-7 years prior to this report) at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced bronchitis. The clinical outcome of the event, bronchitis, was unknown. Pfizer is marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information expected.
Student demonstrated rash from injection site and down the left upper arm about 4mm. Hives noted next to the injection site. Itching and redness along inner left arm and right hand. Vital signs BP 101/78, Pulse -113, O2 - 99%. Student injected 12.5 mg of Benadryl to the Rt deltoid area at 3:47pm. At 4:03 pm patient in good spirits. Redness and itching subsided. Hives are no longer noted. Vital signs BP/- 115/79, Pulse 98 BPM, O2 99%. Lung sounds clear and heart sound normal rhythm.  As per parent, child is doing fine today, Dec. 8, 2021 had no other signs and symptoms.
Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Aug-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient is pregnant and lactating. Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: Reporter details, patient demographics and product information were updated
High fever 102.9-103.4,   Headache, chills, body aches, chest pain.
Developed severe neck pain and headache, severe pain in R axilla with swollen lymph nodes that continues on a daily basis, numbness, paresthesia and pain in R arm hand radiating down from shoulder/upper arm area of injection, myalgias, joint pain in shoulder, elbow, wrist, fingers. Was given 10 day course of Prednisone which was effective during the time I was taking the medications but returned approximately 4-5ays after the medication was completed
Patient received first dose of Moderna COVID 19 Vaccine on 4/16/21 at a medical facility Then received one dose of Pfizer COVID 19 Vaccine on 7/21/21 at a store.
Stomach felt queesy and then my face began to tingle and feel very strange.  This lasted about 2 hours and then went away.  I went to bed and slept it off and have not had any other affects.
Fever of 101-103  for 48 hours, aches, pains, chills, headache for 72 hours, continuing shoulder pain (3 weeks)
pt recvd vax; T 99; 29mar, mom reported T 105;visit on 30mar; coughing, amoxicillin given; no distress on f/u visit;
Increased heart beat, potentially blood pressure but was not checked. Chest pain - tightness.
Fever - 103 day 0, 101 day 1, 99 day 2, 97 to 95 since Sever dry cough day 0 - day 7 Cough since  Gag reflex day 8 through current X-ray indicated URI day 1 No taste or smell starting day 3.  Returned day 12 Covid pcr positive day 2 Covid home test negative day 0 and day 1 Head congestion day 5 through day 9
Patient is in the care facility, we were there to do vaccination for the patient at the time of the vaccination on 03/08, patient was brought to u for vaccination and according  to their record it was his second dose based on their record of last dose on 02/11, we administered the dose at the time and then when we were doing  data log in we realise that patient was given 1st dose in January which hosital did not log and when asekd for the vaccine card hospital said it was in the chart and will bring in after the shot since this is psyc hospital patient needed to be  moved quickly to avoid agitation
Pt had c/o left leg going out and he fell down. States it went numb x 2. Also night sweats. Note Pt was 6 weeks post back surgery.
After the vaccine I only had mild pain for 12 hours. When I had COVID in December 2022, I had high fever, cough, chills, I had a lot of drainage and congestion. It lasted for three days, after 4 days symptoms improved, and I was fine by the end of the day. I went to the doctor after I tested positive.
This consumer spontaneous report (initial receipt 13-Nov-2014) concerns a female patient who was in her early 60 year-old. On 12-Nov-2014, the patient received intramuscular AFLURIA (batch number not provided) 0.5 mL once. On 12-Nov-2014, 1 hour after the vaccine she noticed that her upper lip began to quiver intermittently which persisted at the time of reporting. The outcome was not recovered. Reporter's comments: The reporter assessed the event as non-serious.
15-20 lesions-scattered scabbed on face & chest;no new lesions since 3JUN97;
having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiving the vaccine; tongue as "burning up" and painful; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient's child). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 28Jan2021 as first dose, single for an Covid-19 immunization (At the age of 84 years). The patient medical history and concomitant medications were not reported. On 28Jan2021 (yesterday), the patient received the first dose of the Pfizer COVID-19 vaccine, and noticed her tongue started burning about 2 hours after receiving the vaccine. On 28Jan2021, she was also experiencing body aches and arm pain. The patient described her tongue as "burning up" and painful and she was having difficulty breathing (start: 28Jan2021) because of her tongue. The reporter was taking her mother to the hospital now (29Jan2021). The outcome for all the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Painful arm (could not move at all), fever, chills, migraine headache, unable to sleep, stomach cramps, body aches, swollen lymph nodes under armpit, brain fog. (Previously had Covid in December)
never got the 2nd shot due to the COVID Pandemic; received 1st dose via intercostal route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2020, the patient received the 1st dose of Shingrix (intercostal, left arm). On an unknown date, the patient received the 2nd dose of Shingrix. In JAN-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received 1st dose via intercostal route). On an unknown date, the patient experienced social problem (Verbatim: never got the 2nd shot due to the COVID Pandemic). The outcome of the intramuscular formulation administered by other route and social problem were unknown.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was the patient. The patient received 1st dose of Shingrix over 3 years ago, probably in January 2020 (no specific date provided), and never got the 2nd shot due to the covid pandemic. The reporter consented to follow up. Due to covid pandemic, the patient never got 2nd dose of Shingrix, which led to social problem. The patient received 1st dose of Shingrix via intercostal route, which led to intramuscular formulation administered by other route.
Severe pain at injection site and entire limb. Fatigue, achiness, nausea and stomach ache. Was given vaccination at the time of an infection and am having problems with swollen glands and fever, don't know if these are symptoms from vaccination or infection. I guess that's why I shouldn't have been given the vaccination at the time of an infection.
pt began feeling extremely weak & tired about 2 wks p/vax was administered-lasted about 3 wks;
Syncope, Patient was alert, redness, no sob, slight sweating, light headness. ice pack, fluids, oj and food was given. patient responded to treatment. emt came. Did not take to hospital. Patient declined to go hospital