chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; headache was so painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0153) as dose 1, single for covid-19 immunisation. Relevant medical history included: "headache" (unspecified if ongoing), notes: same headache I had 14 years and then never had it again. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Pain"; HEADACHE (non-serious), outcome "not recovered", described as "headache was so painful". The events "pain" and "headache was so painful" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache.  Additional Information: Consumer reported that she had to go to the ER. They didn't find anything with the headache, but the headache was so painful. Years ago, she had a brain scan and some blood work. Reporter received Tylenol at Hospital.  No follow-up attempts are possible. No further information is expected.
A rash started under both armpits in the middle of the night. The armpits were swollen and welped . The rash continued to spread across my chest and back and down both arms . Went to doctor and got medrol dosepack and triamcinolone cream.
woke up 730AM on 8JUN95, pale, lethargic, vomiting; CBC, UA done; 3+ ketones, high platelets; MD sent to ER; pt was unable to be aroused by MD; blood sugar 52-57; hematocrit 34, platelets 376, WBC 15.2; dehydrated 2ndary viral illness;
Whole body raised papular rash extending from neck down to knees (front and back) with pruritis.
Vaccines had an expiration date of 03/27/2022. This specific batch/lot number was taken out of the freezer beginning of March. No cases of adverse reactions reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX (batch number M224F ?, expiry date 8th February 2021) for prophylaxis. On 31st July 2018 11:30, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This reporter stated that the patient wife came to the pharmacy and just happened to mention that her husband had been experienced side effect from the vaccine. The patient's wife said that over the past few days, he had soreness and pain at and around the injection site. The pain was coming from being painful to the touch. The patient's wife told the pharmacist that the area was about the size of a tennis ball. The side effects had not resolved.
The evening of the second dose night sweats, fever, chills, body aches and nausea. This lasted into the following day. As these symptoms began to subside on 10/20 he started having sharp abdominal cramps every 5 to 10 minutes. On 10/21 he went to the Clinic and they ordered lab work. On Friday the stomach cramps subsided and additionally on Thursday he began sneezing and congestion that lasted several days.
Moderna COVID-19 Vaccine EUA  -   First,  arms swelled up at the my wrists/forearm. Second,  feet swelled up that I had to elevate them and couldn't walk.  Third, feeling  sharp jolts of pain in my feet toward my toes
dizzy; health raced like if I was running for my life and thought I was going to pass out. The worst feeling ever.; I was given 2 shots of the vaccine in the same day; I was given 2 shots of the vaccine in the same day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 17:00 (Lot number: FF2530) at the age of 38 years as dose 1, single and administered in arm left, administration date 12Nov2021 17:00 (Lot number: FF2530) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 2021, outcome "unknown" and all described as "I was given 2 shots of the vaccine in the same day"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "health raced like if I was running for my life and thought I was going to pass out. The worst feeling ever.".  Additional Information: Pharmacist administered both dose of covid-19 vaccine without notifying me he was. He only told me after the fact that I was already poked. I felt like cattle and not sure of the effectiveness of this process since every article I read there has to be a couple of weeks between doses. There was not an observation period after the vaccine either.  No follow-up attempts are possible. No further information is expected.
Mylagias occurred within 3 days of immun. Seen on 4 additional occasions for continued pain & increasing eye/temporal pain.  Considered poss. meningoencephalitis due to vaccine. Admit to hosp for Guillain-Barre Synd. on 15Feb90.
t104 & greater on Thursday 27JUN febrile sz;saw by MD dx w/kawaski virus;mom states MD unsure if sx from vax or virus;pt exp no s/s for past 48hr
Day 12 from Moderna #1 I developed red patches at the injection site.  It only itched if I touched it, and stopped when I took my hand away.  No pain unless I pressed on it.  The next day the patches were slightly smaller and the itch response still active when touched.  No interference with any activities whatsoever.
Pt reported redness, swelling and pain at site of injection. Was seen by urgent care and given BACTRIM for possible cellulitis.
About 1 hour after: sore arm, sore/enlarged lymph node in underarm About 8 hours after: chills, body ache, fever About 16 hours after: severe headache, fatigue
Swelling & pain in left arm, sore neck & headache, body aches, fatigue.
1hr p/vax hands & bottom of feet became itchy;2-3hr later they became fiery hot;next days same sx in pubic area;took DPH;could work & function w/o diff;5 days later pt w/hives,went to ER given 2 inj & prescription for hydrox YZ;
Patient arrived for well child visit.  To limit amount of injections, nursing drew up quadracel not realizing it is recommended for children 4-6 years of age and patient is only 18 months.  Nursing informed of error on Tuesday, September 19, 2023 10:12 AM through email from coding department as injection flagged an error due to age of patient.  Nursing looked into error to confirm which immunization was given and found it was given in error.  CDC contacted to inquire about any harmful or saftey concerns given immunization not recommended for children under 4 years of age. Per CDC on 9/20/22: Generally there is no reason to believe that giving a patient the wrong vaccine would be harmful - even if the vaccine isn't indicated for that patient (for example, because of the patient's age). Often these doses can simply be ignored, unless the vaccine that was given is contraindicated for that patient. In that case, appropriate measures should be taken. -An exception to this recommendation involves the meningococcal ACWY vaccine Menveo. With Menveo, the dry serogroup A component is normally reconstituted with a liquid component containing the C, W, and Y serogroups. If the liquid CWY component is accidentally given alone without the A component, the dose may be counted, unless the patient is planning to travel outside the country.. This is because serogroup A disease is rare in the country. 2- "VAERS" Call: Healthcare providers are required by law to report to VAERS : Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations. An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine. -Healthcare providers are strongly encouraged to report to VAERS: Any adverse event that occurs after the administration of a vaccine licensed, whether it is or is not clear that a vaccine caused the adverse event. -They strongly discourages variations from the recommended: Route, Site, Volume, or Number of doses of any vaccine. 3- "Do Vaccine Administration Errors Represent a Safety Risk?" -Most vaccine administration errors, such as giving a vaccine at the wrong age or giving an expired vaccine or the wrong amount of vaccine, should not cause a safety concern. The problem is usually not that these errors are unsafe, but that the vaccine might not work as well. That is why vaccine doses given in error often need to be repeated.  Mom was contacted on 9/21/23 to discuss but there was no answer.  Nursing left message for Mom to return call to nursing to discuss.
Sudden death 5 days p/DTP/HIB on 11MAR92; pt was seen for well bay check up, was active, alert, & happy, PE was completely nl; Pt seen by M in good hlth; on 16MAR92 pt was placed in playpen @ 5PM & was found dead about 515PM;
Headache, chills, body aches, nausea, low grade fever gone the next morning
Vaccine administered 7/8/12. 7/9/12 in the evening patient noticed some swelling and discomfort. Patient woke up 7/10/12 with more pain, swelling, and inflammation went to emergency room. Received KEFLEX 500 1 Q6H 40 & Prednisone 20 mg 2 daily #10.
Pt had a fainting spell. At first it appeared as if she was potentially having a seizure. After about 3 minutes she came to and was fine. She was examined by EMS and was released to going home own her own with her friends.
On Sunday evening following my vaccination the previous Monday, I had pain in my chest and I thought I might be having a heart attack. It felt like a lot of pressure in my chest.
Case number PHEH2012US003361 is an initial spontaneous report received from a consumer on 07 Feb 2012, with a follow up report received from consumer on 28 Feb 2012. This case refers to a 12-year-old female patient. Concomitant medications included TDAP (other manufacturer, batch number: unknown) given intramuscularly and varicella (batch number: unknown) given subcutaneously. She was inadvertently vaccinated with 0.5 ml intramuscular dose of MENVEO (batch number M100061) MenCWY liquid conjugate component without being reconstituted with MenA on 27 Dec 2011. She was it was reported that, upon realizing only one portion of the vaccine was administered, the nurse reconstituted the MenA component with MenCWY and re-administered the vaccine the same day. No adverse event had occurred since vaccination. Follow up report received from consumer on 28 Feb 2012: Updated concomitant medications.
the injection site of the second dose is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the injection site of the second dose is painful) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (the injection site of the second dose is painful). At the time of the report, VACCINATION SITE PAIN (the injection site of the second dose is painful) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-352986 (Patient Link).
The day after, patient experienced a fever of 102.5 degrees F, chills, headache, nausea, diarrhea and blacked out.
Redness and swelling at injection site, extended up and down arm about 10 cm in both directions.  Blister about 2 X 3 cm.
16MAR pt exp feeling of pressure/chest/shoulders & painful arms & upper body 4 1/2 hrs went to sleep until evening of 17MAR; seen in ER;
sudden onset loss of sight in one eye & seeing swirling colors w/severe h/a;later vomiting then returned to nl w/in 3hr;advised by MD to go to ER;
SOB, heart racing, neck and shoulder pain starting with 24 hours of Pfizer "Booster" She was found to have d-Dimer >4000, elevated sed rate and CRP. Sent to emergency room. Found to have significant pericarditis and transfered to higher level care hospital for emergency care.
Case number PHEH2014US024291, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 14 years old male patient. His medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFs of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the administration (incorrect storage drug). Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
The day after the vaccine was given, the arm was sore, swollen, and red all in her upper arm. She had chills. Told to use ibuprofen, ice, and elevate the limb. Will call to follow up.
Situation: 14yo male came in for first dose Pfizer vaccine. Within 5 mins after receiving vaccine, patient had a seizure for approximately 1 minute. During seizure, patient was incontinent of urine. RN was able to get to patient's side before he fell.   Background: Patient did not alert vaccinator or RNs that he had a history of seizure. Mom informed staff after the event that he had a febrile seizure when he was a young child. She did not disclose what age he was at the time of the previous seizure.   Assessment: RN observed patient in an active seizure for 1 minute in which his body contracted out and his eyes rolled back. She was at his side to prevent him from falling. He was placed on a gurney and moved to room 6 for closer observation for 30 mins.  Pfizer vaccine administered on 5/22/21 at 12:52PM 1255 vitals ? 121/64(83), 97.3F 1257 vitals ? 122/75(90) 1311 vitals ? 116/76, HR 68, 100% O2 1318 vitals ? 112/75, HR 68, 100% O2 1325 vitals ? 111/61, HR 68, 99% O2  Recommendation: MD on call, was called and notified of the event. Her recommendation was for the patient to go to the ED for evaluation and labs. RN called the ED to notify them of the patients intended arrival. The mom agreed to take the patient to ED for further evaluation.  The patient was taken out via wheelchair.
I had the injection on Saturday afternoon and woke up Sunday morning with a rash on my abdomen and a few spots on my right arm. I was clearing my throat over and over. By Monday the rash Was also on my back and now on Tuesday the rash is even larger and even more pronounced all over torso and back. There is a slight itchiness to it but not terribly itchy. I have been taking Benadryl But it has not made it go away.
DVT; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse asked if there is any DVT cases reported following the administration of Pfizer-BioNTech COVID-19 Vaccine. E-transmitting duplicate AE caller already reported a DVT case post vaccination. Caller also asked "Why is there's a statement indicating that individuals with a history of bleeding disorder or taking anti-coagulant should contact their vaccination provider? How did they prove 95 % efficacy? Why aren't antibodies produced after the 1st dose of Covid-19 vaccine?" The outcome of the event DVT was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Very limited information was provided for this individual patient, such as pre-existing medical history, suspect administration details, clinical course and relevant supportive lab data for the reported Deep vein thrombosis (DVT). Pending further details, the Company would handle this reported DVT related to the administration of BNT162B2, COVID-19 immunization, for reporting purpose.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
real achy; had a little bit of fever one day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (real achy) and PYREXIA (had a little bit of fever one day) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (real achy) and PYREXIA (had a little bit of fever one day). At the time of the report, MYALGIA (real achy) and PYREXIA (had a little bit of fever one day) was resolving.            Patient takes concomitant medications but denied providing them. No Treatment information was provided.    This case was linked to MOD-2021-020886 (Patient Link).
Administered via subcutaneous route; This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 57-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   In November 2022, the patient received Influenza vaccine (subcutaneous). In November 2022, unknown after receiving Influenza vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The case was reported by physician. The physician reported that the patient was administered Fluarix or Flulaval subcutaneously. The brand name was not known but health care professional stated it was from GlaxoSmithKline. The event occurred three days ago.The reporter consented to follow up. Additional supportive information: As patient administered Fluarix or Flulaval subcutaneously which led to intramuscular formulation administered by other route.
Calcification of both carotid arteries. Procedures: Left internal carotid endarterectomy with bovine pericardial patch angioplasty. She will be discharged from Medical Center to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
I got the moderna covid vaccine.  About 2 pm the symptoms started with my arm hurting so bad that I couldn't use it.  It then progressed very quickly and by the next morning I ached all over, my arm had visable swelling and felt hot to the touch.   My eyes hurt and I had a migrane, the next day Wed, I had nausea and the aches continued with extreem fatigue and a general feeling of malaise.  The eyes still ached with light sensitivity and nausea.  Thursday saw all the same symptoms but to a lesser extent, the ache in the back of my thighs up into my buttock got a bit worse.  I also felt dehydrated despite drinking extra fluids in the form of black, green and mint and ginger tea.  I couldn't tolerate coffee, most food, and had thrown up on wed after eating some oatmeal.  BRAT was all I could eat and the banana wasn't until thursday.  Today is friday and I feel a bit better, tolerated coffee this am and have some appetite as well.
On 12/31,1/1 exp flu like symptoms. Then on 1/3 got dizzy,sweaty and sat down nurse nearby took my pulse 65. The ambulance was called went to a hospital there was no CT scan capability therefore transferred to another hospital.
This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records. the subject was vaccianted with hepatitis B vaccine (manufacturer unspecified) on 7/11/94, 8/8/94 and 12/8/94. The subject was also vaccinated with Tetramune, OPV, MMR for prophylaxis. The subject was the product of a premature twin delivery. The subject was examined on 5/11/95 due to concerns that the subject was dragging her left leg and delayed motor development compared to her twin sister. On 12/13/95, the subject was evaluated for speech and language delays and social development concerns. At that time, she was assessed to have severe language  comprehension and expression delays. Moderate delays in social and emotional skills were also observed. A language reassessment on 2/10/97 showed continued moderate to severe language impairment, with expressive range skills at the fifteen month level. She was diagnosed with speech language impaired. On 10/6/99, the subject was seen in follow up for attention deficit disorder, and in Feb 2000 Ritalin therapy was initiated. In April 2000 the subject was noted to meet the diagnostic criteria for Aspergers syndrome, and had a diagnosis of ADD, inattentive type. Treatment medications in 2000 and 2001 also include Clonidine, Concerta, and Paxil. By Aug 2000, the subject had been diagnosed with pervasive developmental delay. Additional complaints included recurrent headaches, sleep disturbance, and anxiety. According to physicians notes dated 4/14/03, the subjects problems list included pervasive developmental disorder, anorexia, ADD, chronic sinusitis, sleep disorder, and learning disorder. On 8/23/03 the subject presented with ADD and obsessive compulsive disorder, rule out bipolar disorder, rule out psychiatric disorder. This case was assessed to be medically significant by manufacturer (OMIC).
Severe menstrual period following second dose of vaccine. Period arrived a full week early despite being on birth control and lasted for 11 days when usually only 2-3 days. Cramps were severe and bleeding very heavy. The subsequent two periods have been severe as well but not as bad as the first one  following the vaccine.
Starting at midnight 11 hours after receiving immunization patient experienced 4 hours of uncontrollable chills/shaking (6 blankets didn't help), followed by intermittent shaking next 24 hours. Patient experienced grade 3 injection site redness >100mm, pain grade 3 severe lasting 72 hours, myalgia grade 3 prevented ADL 48 hour, fatigue grade 3 prevented ADL 72 hour, malaise grade 3 prevented ADL 72 hours. Patient missed work (RN) due to adverse effects and spent time in bed. Patient return to work 10/6/2020 with mild fatigue, mild injection site redness, mild injection site pain.