chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw up x1; Didn't know who I was; I couldnt lift my arm; Getting weak; Arm got severely swollen; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced hallucinating (hallucination), didn't know who I was (confusional state), couldn't lift arm (muscular weakness), got weak (asthenia), arm got severely swollen  (peripheral swelling), pain (pain in extremity), fever (pyrexia), headache, fatigue, threw up (vomiting), shaking and shivering (chills) and muscle aches (myalgia).   The patient's medical history and concomitant products used were unknown.   On 03-MAR-2021, approximately 12 hours prior to onset of first event, the patient received their first planned dose of mRNA-1273 (Lot/Batch number: 022M28A) intramuscularly for prophylaxis of COVID-19 infection.   Within the first 12 hours of being vaccinated, the patient experienced minor arm soreness, which ended the same day. The next day, she experienced fatigue, headache, shaking and shivering, muscle aches, was getting weak, threwup once, fever, and didn't know who she was. She lived alone and was hollering for someone to help her. She couldn't get out of bed. She was hallucinating; she thought the floor was wet. Her arm was severely swollen and painful.  The patient couldn't lift her arm.  Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the event is unknown.  The outcome for the events, hallucinations, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, were unknown.; 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, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, a causal relationship cannot be excluded. Very limited information regarding the hallucinations has been provided at this time.  Further information has been requested.
Information has been received from a 16 year old female with a history of migraines who on approximately February 2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced tingling in her leg and pain in her leg. Subsequently the patient recovered. on an unspecified day in 2007, the patient received a second dose of Gardasil. Subsequently the patient experienced tingling in her leg and pain in her leg. At the time of the report, the patient was recovering. Additional information is not expected.
her arm was "quite painful."; muscle ache, swelling; her arm having "a certain heat to it"; her arm was swollen from her elbow to her shoulder; muscle ache; This spontaneous report was received from a 66 years old female patient referring to herself. The patient had no concomitant medication. The patient's current condition included arthritis. The patient had none drug reactions/ allergies.  In September 2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (second dose, lot # T020638, expiration date 26-FEB-2020; dose and route were not reported) for prophylaxis (reported as scheduled vaccine).    The patient reported that a few hours after she received her 2nd administration of the vaccine, her arm was quite painful. She reported that, overnight, the pain ramped up and her arm was swollen from her elbow to her shoulder in the morning. She reported having significant muscle ache, swelling, and her arm having a certain heat to it for 72 hours, which slowly dissipated after 48 hours. She inquired if these kinds of reactions were normal to experience with the vaccine. None lab diagnostics/studies performed. Device was not available for evaluation (obtain was false). The outcome of the events was recovered.     The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Erythema mulliform after small pox vaccine, pruritic, hx of eczema. Referred to dermatologist.
Pt received his his first Hepatitis A vaccination on Monday, August 19th at 10:00 AM.  On August 22nd at 6:00 PM he was lethargic, did not want to eat dinner or drink anything and fell asleep.  He awoke at 9:30 PM and had a high fever of 102.5, was lethargic, vomited 4 times and had a bloody nose.  Gave him Motrin at 10:00 PM and he vomited again.  His fever went down to 101.2 at 12:00 AM and then to 98.3 at 2:00 AM.  The next morning he was fine.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 01/10/2001 the patient presented with vesicles consistent with herpes zoster on her left leg and lower back. The physician sent off for a culture and analysis. The culture came back positive for varicella virus.  In follow up, the physician describes the herpes zoster at the injection site, down the left leg, on the left thigh and back. The patient was irritable. Additional information has been requested. Per F/U 6/17/02: The physician describes a previously healthy child without any known immunosuppression, that does not attend daycare and is not known to have inu tero or pre-varivax vaccination exposure to chickenpox. F/U indicated that the physician reported that the pt had recovered completely from her experience and that she actually had not returned for subsequent follow-up visits. Additional information has been requested.
the patient had flu vaccines 2/20/23 and 3/31/23 for 2022-2023 flu season.  He also had flu vaccine 9/29/23 for 2023-2024 flu season.  An extra dose of flu vaccines was given on 11/3/23 to the patient.  No harm was caused to the patient. Incident report was filed. Parent was notified.
Moderate pain in arm starting within 12 hours and lasting almost 3 weeks.  Swelling in arm which became a tender, firm nodule about 2 in.  The pain and nodule were slightly above the injection site extended up toward the greater tubercle of the humerus.  The pain subsided by week 4, but there is still a 1 inch lump and some tightness when I move my arm posteriorly.  I also had a headache and chills the first 2 days, but that resolved quickly.
NO ADR YET, Patient may have been given 1 ml instead of 0.5 ml
Swollen bottom lip; Red marks under skin/Tiny red spots under skin; Tiny red spots under skin, itchy but no hives; Itchy throat and tongue; Itchy throat and tongue; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266 and Expiration date was not reported), via an unknown route of administration in right arm on 28Feb2021 at 09:30, as a SINGLE DOSE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient medical history included high risk asthma and the patient had allergies to erythromycin, amoxicillin and penicillin. The concomitant medication included pantoprazole (patient received within 2 weeks of vaccination). On 28Feb2021 at 10:45 (same day of vaccination), the patient reported tiny red spots under skin, itchy but no hives, swollen bottom lip, itchy throat and tongue. The outcome of the event tiny red spots under skin, itchy but no hives was recovering whereas, for other events was recovered in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
I took a bite of an apple around 2 pm the day of the injection and the roof of my mouth immediately blistered up.  The glands at the back of my tongue were inflamed, my epiglottis hurt and my esophagus hurt the whole way down to my stomach in my chest.  My inner ears felt pressure and throbbed.  By that night my whole tongue hurt and I couldn't touch anything to it.  This reaction stayed like this for 2 days and each time I tried to eat anything -even soft foods like yogurt- the roof of my mouth blistered up.  My esophagus and epiglottis felt damaged.  I ended up not eating much for a couple of days due to the pain and reactions.
red lines on arms and legs; This case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received Shingrix at an unknown dose and Tdap Vaccine at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced erythema. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The patient received Tdap and Shingrix in separate arms and presented approximately 2 weeks later with red lines on arms and legs.  The patient was treated with yeast infection medications and steroids.
This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 31-year-old male subject had received the following vaccinations: On 01 September 2011, an injection of ACAM2000 (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and INFLUENZA (manufacturer and lot number not reported). On 13 September 2011, the subject had an abnormal ECG. On 18 September 2011, the subject had a normal echocardiogram. The subject had a normal troponin I on 16 September 2011. The subject was diagnosed with unspecified chest pain on 13 September 2011. The subject had a medical history of palpitations/pounding heart without exercise, chest pain, chest pressure, abnormal ECG and shortness of breath. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Patient received his 3rd shot too early. He was supposed to receive it 9/29/2022. However, parent made online appointment, and Clinical staff didn't catch the error until vaccine was already administered.
asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; asking on how to differentiate between side effects from COVID vs vaccine side effects/also wondered if he needs to quarantine; swelling of glands in throat/lymphadenopathy in throat; headache; Feeling a little fluish; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot number and expiry date were unknown), via an unspecified route of administration on 21Dec2020 18:06 at a single dose for COVID-19 vaccination. Medical history included diet controlled Type 2 Diabetic diagnosed 5 years ago in 2015. There were no concomitant medications. The patient previously got Shingles vaccine and it was a two dose vaccine. He felt a little bit like he did now after receiving the second vaccine. He felt fluish for 8-12 hours the day after receiving the vaccine. He has gotten lots of vaccines like Flu and has no responses. The patient does not have prior vaccinations within 4 weeks. The patient received the vaccine yesterday (21Dec2020), and maybe an hour ago on 22Dec2020, he started feeling swelling of the glands in throat or lymphadenopathy in throat and a little bit of headache. He has a question that he cannot find the answer to anywhere. The patient is asking on how to differentiate between side effects from COVID vs vaccine side effects? His temperature was 98.1 on unspecified date. He did not have an exact time frame for when it began. He stated, "you get swelling in glands and then you notice it." He noticed about 2 hours ago and it is getting worse. Now he is feeling like he is sick. He has been volunteering and giving the vaccines over the past two days himself. He is feeling now a little fluish. He doesn't know how to say it other than tired and just doesn't feel good. He would go to work like this and does not feel it is medically significant. He does feel like he is deteriorating but that is only a guess. He felt a little worse than an hour ago. He also wondered if he needs to quarantine because he is signed up to give the vaccines and would not want to do that if he should not. No ER or physician's office required. The outcome of the events was not recovered.  Information on batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves years old female patient who was administered with an expired dose of IMOVAX RABIES (batch number: M13142M, Expiration date: 19-Jun-2018, dose was not reported) in the left deltoid on 22-Jun-2018. The patient's medical history, previous medications were not reported. The patient was not pregnant, but last menstrual period was not known. It was a case of expired vaccine used. It was not known whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
He has now been diagnosed with traumatic brain injury related to the vaccines he received; the reaction started with injection site swelling; flu like symptoms that sent him to that hospitals that night; he has a gene mutation that would be more affected from receiving vaccines; This spontaneous report has been received from the patient's mother referring to a male patient of unknown age. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# 647523/0633R, expiration date not reported, but upon internal validation established as 13-JUN-2007; strength, dose, and route were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (human serum albumin (HAS)) (M-M-R II) (lot# 649754/0378R, expiration date not reported, but upon internal validation established as 24-MAR-2007; strength, dose, and route were not reported) for prophylaxis.  On an unknown date, the patient experienced injection site swelling and the flu like symptoms. He was sent to the hospital that night. Then, on an unknown date, the patient cried no stop for two weeks and his eyes went side away, it was also reported that he became like a vegetable (for example, not able to walk, or take care of himself). The reporter stated that he had stayed this way for years and his recovery had been really slow. He was diagnosed with traumatic brain injury related to the vaccines. The patient had sought medical attention. Treatment (unspecified) was given. A gene mutation was also found out that would be more affected from receiving vaccines. The mother reported that she wrote letters to the company years ago when the events happened and did not received any response back. Currently, the patient still needed a lot of help for activities of daily living, he was still per mother healing. The outcome of traumatic brain injury was not recovered. The outcome of injection site swelling, the flu like symptoms, and gene mutation was unknown.  The reporter considered all the events to be related to the vaccines.  Upon internal review, traumatic brain injury was determined to be medically significant.
Severe crushing headache in bilateral temporal lobes; Severe fatigue day after; This is a spontaneous report from a contactable nurse which is also the patient. A 36-year-old non-pregnant female patient received 1st dose of bnt162b2, intramuscular in the left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included polycystic ovaries (PCOS), anxiety, depression and attention deficit hyperactivity disorder (ADHD). The patient has no known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN), and escitalopram oxalate (LEXAPRO). It was reported that the morning after vaccine, 19Dec2020 08:00, the patient awoke with severe crushing headache in bilateral temporal lobes that resolved in a couple hours with acetaminophen  (TYLENOL) and rest. The patient also had severe fatigue day after. Added that there's also fatigue on 2nd day after vaccine but much more mild than 1st day. All symptoms resolved at 48hrs. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. The events were assessed as non-serious. Therapeutic measures were given for the events. Outcome of the events was recovered in Dec2020 after 48hrs.   Information on the lot/batch number has been requested.
he had a side effect from the second shot of his Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine). At the time of the report, IMMUNISATION REACTION (he had a side effect from the second shot of his Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient states he had a side effect from the second shot of his Moderna vaccine. Patient said the vaccine destroyed his life and not safe for everybody.  No treatment information was provided.   Reporter did not allow further contact
Got what new reports are calling "delayed cutaneous reaction". After first covid injection, 7 days later got a ~6 x 4 raised warm red wheal on shot arm about 5 cm below injection site with no part attaching to injection site. After second vaccine 1/29/21 getting similar reaction but (so far) not as big or warm. it is 45 hours since last injection and got it on opposite arm as first injection.
Allergic reaction (mouth and lip swelling) after eating almonds and pecans.  I have eaten almonds and pecans my entire life and this is the first allergic reaction  ever.  I took  fexofenadine and the swelling abated after several hours.  I have not eaten nuts since,  and there has been no recurrence.
Hot feeling on arm.  Itchy all over my body.  Mainly on arms and trunk,  ears  face nose.  neck head . Heavy feeling in  chest. Pain around ribs stomach area  an hour after shot.  Pain in  area of shot. Headache  and ache in shoulder of arm with shot.  Back ache.
40 hours post vaccination : report: "Charlie Horses" muscle spasms to right leg x 4.5 hours continuously
This initial spontaneous case was received from a nurse via another manufacturer under reference number 1-5584828450. A patient of unknown age and gender with no reported medical history experienced cow pox after receiving an unspecified smallpox vaccine (manufacturer unknown; lot number not reported) at an unspecified time in the past. No further information was available at the time of the report. The outcome of the patient was not reported. Documents held by sender: None.
Patient reports allergy to potassium as itching with a history of hives. Patient was aware of the risk vs benefit and potential of ADE due to allergies  prior to receiving the vaccine. Patient was observed for 30 minutes.   Patient experienced itching about 25 minutes post vaccine. Diphenhydramine 25mg was given to patient.
Patient had 2 waves of cold sweats during his 15 minutes waiting period.  Patient also felt palpitation or racing heartbeat.  Throat became scratchy.  Globus sensation.  Denied swelling of the throat.
Not sure if this is related to covid-19 or from vaccine. I am having cardiac symptoms, echocardiogram scheduled.
Fatigue, fever, headache, muscle ache, nausea Severe pain at injection site
Patient received their second dose too soon; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 037A22B and 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 21-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 21-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their second dose too soon) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.