chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 20-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 20-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reported received from the same reporter. Additional information has been requested.
Pt got chills, rash under arms with itching, HA. Injection site red & swollen. Fever spiked at 7pm to 102.4, then fever broke. Swelling of site gone by 7/16/11 as well as itching & rash. 7/16 felt "queasy" & very tired. Felt back to normal by 7/18/11.
WOKE UP AT 2AM ON 7/20/21 WITH AN ITCHY RASH ON ARMS, LEGS, AND FEET. TOOK BENADRYL AND IBUPROFEN, THE RASH FINALLY GOT BETTER AS OF 7/22/21. HAD BODY ACHES AND FELT BAD REST OF DAY 7/20/21. ON EVENING OF 7/20/21 SHE PASSED OUT IN HER HOME WHEN GOT UP FROM SITTING DOWN. SHE IS UNSURE HOW LONG SHE WAS UNCONSCIOUS. SHE HAD SPILLED HER TEA ALL OVER HERSELF AND FLOOR WHEN SHE AWOKE. SCARED HER.
Low energy,   cramping, body ache, chills    I almost called 911 for emergency, (NB,  I have never called 911 in my life!)   I thought I was going to die!  If my symptoms got any worse I knew I would die
Reaction unspecified to the 3 shots; Got 3rd dose and is not immunocompromised; They had arm pain pretty immediate, the same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day), VACCINATION COMPLICATION (Reaction unspecified to the 3 shots) and EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day) and EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised). On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction unspecified to the 3 shots). On 12-Oct-2021, EXTRA DOSE ADMINISTERED (Got 3rd dose and is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (They had arm pain pretty immediate, the same day) and VACCINATION COMPLICATION (Reaction unspecified to the 3 shots) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354077, MOD-2021-354097, MOD-2021-353213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Significant follow up contains added Batch number.
On 11/24/99, the pt developed rash with slight fever. She had a total of 15 lesions, mainly on torso and face. Subsequently, the pt recovered completely from her experiences. The pt's brother was reported to have had a similar experience following vax.
The patient presented to the emergency department after falling and hitting his head. Upon presentation to the ED, the patient tested positive for COVID-19 (on 04/10/21).
Patient received a third shot because the facility did not know he had gotten a shot at an earlier facility. Patient had dementia and could not be asked if he had a previous covid shot.
was not feeling well; white count was found to be slightly elevated; hematoma on buttock; fell on ice; first dose in November of 2019; injection site was warm; injection site was / puffy; had fatigue; achiness; numbness and tingleness of the lips; tingleness of the lips; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (many years ago patient had shingles). Previously administered products included Shingles vaccine (received the old Shingles vaccine (unknown manufacturer)).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced numb lips and tingling lips. On an unknown date, the patient experienced injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma, fall and incomplete course of vaccination. On an unknown date, the outcome of the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain and unwell were recovered/resolved and the outcome of the increased white cell count, fall and incomplete course of vaccination were unknown and the outcome of the hematoma was not recovered/not resolved.   It was unknown if the reporter considered the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma and fall to be related to Shingrix.  Additional details were provided as follows: The age at vaccinaton was not applicable for the second suspect vaccine. The patient received 1st dose and soon after receiving the vaccine at the pharmacy she experienced numbness and tingling of her lips which resolved in 20 minutes. The patient had reported it to health care professional, but he/she informed that it was not from vaccine and that it was a year ago so she would be immune to taking the second dose. The patient's injection site was warm and puffy. The patient later had fatigue, achiness and was not feeling well, which also had resolved. The patient did not receive the second dose till the time of reporting, which led to incomplete course of vaccination. The patient was recently fell on ice and had a hematoma on her right buttock and her white count was found to be slightly elevated. The reporter consented to follow-up.
Got him up in the morning after he had gotten the vaccine the day before.  Sa t him down on the toilet and he immediately had a major seizure.  Came out of it, let him sit for 5 minutes, got him up and sat on the chair, gave some juice and water, and he was back to normal.   He had diarrhea the day of the vaccination and the day before.
STOMACH STARTING TO HURT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SLEEP DISRUPTION; FEEL HORRIBLE; COUGH; HORRIBLE HEADACHE; This spontaneous report received from a parent concerned a 28 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. Patient's concurrent conditions included: alcohol user (social consumption) and non-smoker. Patient had no known allergies and he did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced cough, horrible headache, sleep disruption and feel horrible (symptoms only lasted one day). Patient was really sick (described as, 8.5 out of 10). On 01-SEP-2021, the patient had terrible cough, fever, no appetite and had rapid test done for COVID-19 which came positive (suspected clinical vaccination failure and suspected covid-19 infection). On 02-SEP-2021, the patient's stomach started to hurt, patient was ill and was supposed to be in quarantine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep disruption, feel horrible, cough, and horrible headache on 11-MAR-2021, had not recovered from suspected covid-19 infection, and stomach starting to hurt, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210906282-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Not really adverse...just arm sore, big time, felt nauseous, headache,  slight fever, chills, clammy skin and very very tired! Slept most of the 14th... feeling unwell! Did not have that experience with the 1st dose . Today is the 15th and I feel so much better!
Headache, neck pain, nausea, body aches, shakes, and  Erythema multiforme. Beaches and neck pain began in the am on 8/20. Lesions began that evening with severe shakes. The lesions started in the elbow crease of left arm and armpit. Then to the right elbow crease. Then to the right groom area and left armpit. Then the left deltoid. Top of right foot and left calf. Dermatology visit 8/22. Told to take antihistimibe for itching and the swelling and steroid cream.
Reoccurrence of shingles in right buttock. Shingles occurred in this same site before when had 1st dose of Pfizer vaccine in April, which is why I switched vaccine.
10x12cm erythema, induration, warmth and tenderness expanding out from R thigh at central injection site-progressing at 48 hrs. Keflex suspension prescribed for possible cellulitis.
I'm not sure which brand I got. After getting the vaccine, I became fatigued then that weekend,  my lymph nodes swelled so bad that I went to clinic. From there. I have had numerous problems,  pain, swelling, fatigue, thought blocking. Anxiety, problems walking due to pain and tingling, numbers to my lower abdomen, ringing in my ears, weakness, spots in my vision, troubles with lungs/asthma, chest pain, hot flashes, sweating profusely, etc. Initially was given steroids and have had to repeat those.  Have been to a lot of doctors.
Headache, fever ,chills, body aches, inching from head to toe,  Face tingling, body aches, joint pain, fatigue, nausea, coughing, chest tightness, SOB, hard to breathe, chest heaviness, swelling with red lump in arm at injection site, arm pain, stabbing pain in arm pit area of injected arm.
PFIZER BIONTECH COVID-19 VACCINE,BIVALENT. Patient is 9 years old. Received Pfizer bivalent booster for 12+years.
Wednesday, January 20, 2021  11:15 am: Received 2nd dose of Moderna COVID-19 vaccine  4:00 pm:   Injection site started to ache and got worse throughout the night. 09:00 pm:   Headache started Thursday, Jan. 21, 2021 01:00 am:   Headache was worse and body aches started.  Took Tylenol.  6:00 am:   Headache and body aches were back, and started to have chills.   Could not sleep all night. Took Ibuprofen and Allegra-D.   08:00 am:   Finally slept.  12:00 pm:   Woke up with headache and body aches.  Took Tylenol. Went back to sleep. 04:30 pm: Woke up 06:00 pm: Headache, body aches (not as bad as earlier in the day).  Took Ibuprofen. Injection site sore all day. Friday, Jan. 22, 2021 06:30 am: Woke up with no headache, less body aches, and injection site less sore.    Took Tylenol.
Information has been received from a school nurse concerning a 15 year old male who on 5/16/2000 was vaccinated with a dose of varicella virus vaccine live. On 4/4/2005 the patient experienced chickenpox and developed impetigo in his lesions. Unspecified medical attention was sought. It was noted that the chickenpox stemmed from the one wild type case. There was no outcome reported. No product quality complaint was involved. Additional information has been requested.
Patient received shingles vaccine in 2006. As of 06/08/11 she was diagnosed with shingles.
Patient reported swelling and pain on ankle 36 hours after receiving vaccine that lasted for 3 to 4 days.
The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.; No Adverse Event; Patient received vaccine after 30-day Use By Date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.).    Concomitant drugs were not reported.  Number of doses/vials: around 50 doses from 5 vials.  The vials were initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details were not given.
1.5 days post vaccination client chills and fatigue with L upper quadrant abdominal pain under rib cage. Constantly present but worse with palpation. Client also reports nausea. He vomited x1 Wednesday night of yellow bile.
pt exp apneic episode & became cyanotic;pt did recover p/mom hit on back & called name;
Severe chills, shaking, dizziness, fever (102.4 F), soreness. Started about 6-8 hours after vaccination and lasted for roughly 36 hours.
Approximately 1 hour after vaccination patient felt lightheaded.  That evening she developed a headache and felt like she had a "hang over" the next morning.  Patient stated that this feeling lasted for 1 week, but now she is feeling better.
vertigo dizziness symptoms; eye bluriness; diarrhea; tingling in my feet and hands; dizziness; nausea; fatigue; hot; inflamed; ITCHY; bad reaction size of a baseball; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness) and DIARRHOEA (diarrhea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy, Radioactive iodine therapy and Dermal filler injection (dermal fillers under the eyes) in 2020. Concomitant products included LEVOTHYROXINE for Thyroidectomy.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball) and VACCINATION SITE ERYTHEMA (red). On an unknown date, the patient experienced VERTIGO (vertigo dizziness symptoms), VISION BLURRED (eye bluriness), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE INFLAMMATION (inflamed), VERTIGO (vertigo dizziness symptoms), DIARRHOEA (diarrhea), PARAESTHESIA (tingling in my feet and hands), DIZZINESS (dizziness), VACCINATION SITE PRURITUS (ITCHY), VACCINATION SITE SWELLING (bad reaction size of a baseball), VACCINATION SITE ERYTHEMA (red) and FATIGUE (fatigue) had not resolved and VISION BLURRED (eye bluriness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
knock him back deafness rash; knock him back deafness rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: 50fc3182) via an unspecified route of administration on 03Sep2021 (at the age of 57-years-old) as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Sep2021, the patient experienced knock him back deafness rash. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
At about 9 AM on 5/11/2022, I began to have body aches and a headache. I also had a bad taste in my mouth. I felt so bad that I left work early and went home. At around 1 PM, I took NyQuil and went to bed. I got up at around 5:36PM and stayed up for a little while. I took some more NyQuil at around 8 PM and went to bed for the night. At around midnight or 1 AM that night, I got up and went to the bathroom. I felt really achy, so I took some Tylenol and went back to bed. I got up at around 7 AM on 5/12/2022. I still felt really achy, so I took some more Tylenol and call in sick to work. At around 11 AM, I took an at-home COVID test, and the result was positive. I took another at-home test around 11:45 AM to make sure there was no error, and the result was again positive. I then called the doctor's office, and I was told to come to urgent care to be tested. I went to urgent care and underwent another test. At around 7:00PM, I called the clinic to see if my test results were ready, and I was told that I had tested positive for COVID-19 and negative for influenza. On 5/13/2022, I was able to get in touch with the triage at the clinic, and I was told I would be prescribed Paxlovid. I finally got the Paxlovid on the night of 5/13/2022, and I was advised to take 3 pills in the morning and 3 pills at night. At the time of this writing, I am starting to feel better. I'm still very fatigued and weak, but I feel less achy. I have been able to move around more and do some chores. I did an at-home test on 5/16/2022, and the result was still positive. I plan to take another test on 5/17/2022.
04/27/2022 2 or 3 hours after my vaccine, my left elbow started aching. This continued for 2 weeks. Once a month, I would start having random pains, which I thought was in my joints, but know now it was in my muscles.
joint pains; muscle aches; Headache; feeling of being cold (not chills); This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included pro-inflammatory state. It was reported that patient had started a weight training program on the same day as the vaccination and suspected that it might have induced a pro-inflammatory state. Allergies to medications, food, or other products was reported as not to the patient's knowledge. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), cholecalciferol (VITAMIN D3), glucosamine (MANUFACTURER UNKNOWN) and chondroitin sulfate (MANUFACTURER UNKNOWN) all for unknown indications and since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021 at 08:00, the patient experienced joint pain, muscle aches, headache and feeling of being cold (not chills). Therapeutic measures were taken as a result of joint pain, muscle ache, headache and feeling cold included treatment with naproxen for the next 3 days. It was reported that these symptoms had continued despite the treatment with naproxen for 3 days. The clinical outcome of the events joint pain, muscle aches, headache and feeling cold were recovered (reported as-by day 5 post-injection the symptoms had gone) at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 5 year-old male with no known allergies and no relevant medical history who in 2002 "at 4 years of age" was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. In 2003, "at 5 years old", the patient "had breakthrough chickenpox, not full blown", also reported as a "vesicular rash". There was no relevant diagnostic or laboratory tests performed. Unspecified medical attention was sought. The reporter noted that they could not remember the patient's name. Subsequently, the patient recovered. There was no product quality complaint involved. No further information is expected.
My daughter passed out 2 times within 5 minutes of receiving her first dose.  She complained of being nauseous after both fainting episodes.  We gave her water and orange juice and she ultimately felt better after about 25 minutes of resting.
Information has been received from a health professional concerning an 8 year old male who, "6 years ago," in approximately 2000, was vaccinated with a dose of Varivax. "Two years after receiving the vaccination," in approximately 2002, the patient developed a severe case of varicella, which resulted in the patient being hospitalized. The number of lesions was not specified. The length of the hospitalization was unknown. It was noted that the event improved. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
I couldn?t drink water a a quick pace without the feeling of throwing up if I continued. I almost threw up the 1st day it happened.
approx 5min p/vax pt c/o dizziness, lightheadedness progressing to difficulty breathing 3cc epi given breathing improved;EMS called transported to ER-eval & released;