chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started hearing voices; Fever; some chills; I was like feeling sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer: unknown), for COVID-19 immunization. The following information was reported: HALLUCINATION, AUDITORY (medically significant), outcome "unknown", described as "I started hearing voices"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "some chills"; MALAISE (non-serious), outcome "unknown", described as "I was like feeling sick".  Additional Information: I would expect that there would be some better phone connection from the Pfizer company that makes the Pfizer vaccine and competes against Moderna. Really that is pretty petty but compared to the report that I am about to make about my experience and side effects that I have experienced with the vaccine. Consumer stated Well, I took the vaccine and I got some side effects of the second shot, when I got the second shot. The first shot, I didn't have anything that I was aware of but then when I took the second shot. Do you know what I mean And they have no heart. It is just about money, shareholders and it just makes me sick. At least I could just say that you as a representative, working for Pfizer, I did read the story about how the mRNA vaccine was created. It is very interesting. The scientists, that they spend a technology to get approval very fast but what would you like to know, that is what I would like to know.Side effects: Consumer stated, My side effects were I had a fever, some chills, I was like feeling sick and I started hearing voices after that. Now, I don't believe in the whole microchip thing, like there is microchips in it because I don't think that would be the best interest for shareholders but I did have a fever.Is that really relevant if I am a doctor or not, if I am just calling, if I just want to make a phone call without disclosing that is that alright because I would like to see how they are treated when they call when without being given special treatment. On confirming if the consumer wants to know how the side effects are treated, Consumer statedNo, I didn't say that. What I am trying to say is that it might be hard to communicate verbally because it is a physical sensation that a patient (not clarified) of mine got and he said he called up and they gave him kind of peculiar advice how to deal with it.  Follow-up attempts are completed. No further information is expected.
Breakthrough COVID  first vax  1/26/2021.  Pt via ems comes for AMS last known well time of 1500. rehab staff report pt found unresponsive at 1715 with oxygen sat of 80%2L. Pt placed on 5L NC up to 85% per rehab nurse. EMS reports initial HR 44, gave 0.5mg atropine.
Pt devel upper resp infect 4 hrs p/recvd 1st dose of Hep B (Recomb) sx resolved over a period of 4 days;
Employee received vaccine 1300 hrs. on Mon. 11-19-12. "Mid-morning" on Tuesday, 11-20-12, she developed red "hive" about 2 inches in diameter. It was itchy, but no pain. There also was a purple bruise "about size of silver dollar" at injection site. On Wed. at 4 pm she saw Dr., an associated of her PCP, Cephalexin ordered x 10 days. Resolved. She notified EH after 2nd dose ordered on 12/17/12 - not given.
Friday night feet started going numb as walking, Sat am couldn't bear weight on legs, progressively became worse, then Sunday hands went numb.  Mon AM - went to chiropractor, then after adjusting was encourgaged to go to hospital if get worse.  At work that day became worse, dizzy, dilated pupils.  Went to urgent care - EKG was normal.  Transfered to ER, did full workup and admitted to hospital, neurologist diagnosed Guillain-Barre on Tuesday night after EMG tests.  Started on IVIG Tuesday night, received another dose on Wednesday, Thursday had horrid headache - determined reaction to IVIG.  Neurology noted improvement on Friday and cleared to go home.  Did not receive more than 2 doses of IVIG.  Did not require plasmapheresis.  Sent home on Friday and slowly recovering at home.  Numbness is resolving.
Felt tired; Feeling achy; Feeling achy/ muscle pain; This case was reported by a consumer and described the occurrence of tiredness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and sickness. Previously administered products included Zostavax (Negative for zostavax).   On 14th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced tiredness, pain and muscle pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tiredness and muscle pain were not recovered/not resolved and the outcome of the pain was unknown.   The reporter considered the tiredness, pain and muscle pain to be related to Shingrix.  Additional details were provided as follows. The age at vaccination was not reported. Patient previously received the Zostavax vaccine and found negative for that. Patient had Shingles and sickness in past. Patient received the 2nd dose of Shingrix on 14th December 2020 and felt tired and was feeling achy/ muscle pain. Patient received medication Tylenol and felt better than the day before reporting day. Patient was not completely recovered otherwise no fever, no GI symptoms and no headache. Patient stated that her husband and her three friends also had the Shingrix shots but did not experienced any symptoms and was comparing whether they was pre-treated with Tylenol or not. She also stated that it might be due to she had previous history of Shingles and her husband and her three friends was not having any history of a prior outbreak of shingles and they never had a shingles outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248570:Same reporter
Starting in the morning on Sunday, April 18th I started with a headache and achy muscles/joints.  This quickly escalated to chills/fever and just not feeling well in general. On Monday morning I woke with the same symptoms as well as the addition of nausea. At around 10 am I vomited. I continued to feel the same symptoms. I called my primary care doctor  on Monday, she said that she thought it was a reaction and to follow up the next day if symptoms worsened. On Tuesday my employer asked me to get a COVID test before returning just to be sure.  I went to Urgent Care and saw the doctor. Symptoms were the same as Sunday/Monday. He said he thought it was a reaction as well. Wednesday morning I woke up with similar symptoms but did have an appetite. I continued to feel better throughout the day, continuing to hydrate and eat small portions. Today (Thursday) I am back to work, still feeling very fatigued, but no fever/chills/headache/nausea/aches.
Fatigue, mild headache, radiating pain from forearm through the shoulder lasting roughly 4 hours. Soreness persisting at injection site 24+ hours after injection.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date of the product was 06-Apr-2010 which was reassigned to 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
face felt droopy/diagnosed with Bell's Palsy; felt like her face was swollen; face became physically swollen and numb; left side of her face and the left "part of her tongue" became swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy) (seriousness criterion medically significant), SWELLING FACE (felt like her face was swollen), HYPOAESTHESIA (face became physically swollen and numb) and SWOLLEN TONGUE (left side of her face and the left "part of her tongue" became swollen). At the time of the report, FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy), SWELLING FACE (felt like her face was swollen), HYPOAESTHESIA (face became physically swollen and numb) and SWOLLEN TONGUE (left side of her face and the left "part of her tongue" became swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: negative negative for evidence of stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports she was negative for respiratory distress or difficulty breathing.  Treatment included two unknown oral antibiotics and oral steroids.; Sender'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.
Went to bed around 10, woke up an hour later with tingling legs, sweats and feeling like my face was on fire. In the morning, all of my lymph nodes were swollen and very painful. Swollen lymph nodes lasted for over a week.
Patient inadvertently received vaccine after published expiration date of vaccine. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 on date of administration of vaccine. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date (reported as "several years ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for prophylaxis, and was currently in the office now for her second dose. No adverse effects were reported in the patient. This is a non-valid case due to no patient identifiers.
I have been experiencing more pronounced tinnitus since my COVID vaccination. My first dose was on March 5, and on March 9 or 10 I awoke with loud ringing in my right ear, louder than I had previously experienced. The tinnitus subsided to some degree and then re-emerged loudly within the past week, around April 25. I received my second dose on April 2, so this is almost 4 weeks beyond that date. The disturbance in my right ear is quite loud. The left ear is also ringing, but not as much.  I have had tinnitus for some years, but I would like to register my experience because of the timing of this most recent pronounced increase in disturbance.
Sever pain in my left arm, it?s so bad that I can barely move my arm. It brings me to tears easing my arm from my side more than a few inches. I have a pretty high pain tolerance and this is unbearable. I am unable to dress myself, I have been unable to leave my apartment because I can?t use both my arms which is needed to operate the old elevator in my building, and working at my computer has been very difficult. I can rest my hand on the keyboard to type but the consistent pain leaves my mind focused on my arm and not the work I need to get done.   I think the injection was given way to high on my arm, it is less that 1/2 inch away from the edge of the tip of my shoulder. Higher than any other shot I have ever received.   It has only been 27 hours since the pain started but it has not gotten better.
Pt. reports she felt achy from Fri. evening (1/28/11) through the weekend and then on Wed. (2/2/11) she broke out in a rash. Rash started on hands and feet and then spread. Reports it looks like a sunburn. Pt. is taking BENADRYL now.
Fever still didn't subside after 1 week of the 2nd dose; This is a spontaneous report from a contactable pharmacist.A 53-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL4262) as 2nd dose, single for covid-19 immunization.Medical history included hypertension. The patient's concomitant medications were not reported. Patient had no known allergies.The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Jan2021 (Batch/Lot Number: EJ1686) as 1st dose, single for covid-19 immunization and experienced fever run between 101-102 with medications along with chill. No other vaccine in four weeks and medications in two weeks within vaccination. Patient had no Covid prior vaccination and did not tested for Covid post vaccination. On an unknown date, the patient experienced fever which still did not subside after 1 week of the 2nd dose. No treatment was received for events. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL1284), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL3302), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; negative; positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Rebound COVID occurred at 4 days following completion of Paxlovid treatment and was confirmed through home antigen test. Previous negative home antigen and negative PCR tests were received 4 days following initial infection on the date Paxlovid treatment was completed (6/26). Current symptoms include headache, sore throat, body aches, running nose, congestion and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
PATIENT RECEIVED WRONG DOSE OF VACCINE AT ADMINISTRATION - RECEIVED 1ML INSTEAD OF 0.5ML. NO S/SX OF ADVERSE REACTIONS NOTED AT THIS TIME.
With 1st 2 doses I had fever and tiredness for 2 days.#rd day I felt better. With 3rd dose, I became ill next day, fever tiredness, sleepy.The symptoms kept getting worse. Brain fog became as bad as when I had covid, no appetite extreme exhausion, Low grade fever , loss of taste, Neuropathy symptoms worsened, until started taking prednisone. Acetaminophene did not help to eliviate symptoms. I had cytokine storm following 3rd dose of Covid 19 vaccine
Patient states that she experience soreness and swelling under her right arm extending to her breast. She described that it felt almost like she pulled a muscle.
This spontaneous report has been received from an unknown reporter and refers to a patient of unknown age and gender. On 08-OCT-2014, the patient was vaccinated with M-M-R II which underwent temperature excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
2 days after Immunizations on Left arm (deltoid area), developed swelling, warmness, induration, erythema, and tenderness. Extending downwards and around 15-20cm, DX: Cellulitis. Cephalixin RX, will be re-evaluated in 1 week.
I had Covid 19 in Decmeber and within 4 hours of getting this vaccine I started having all the same symptoms I had with Covid with the same intensity. The first night I had chills so badly, I really thought I was going to die.  These chills actually may have been worse than the ones I had when I had the Covid 19 virus.   Chills, fever 100.2, nausea, aches, extreme thirst, headache, fatigue, dizziness and weakness.  The reaction was so severe that I do not plan to get the second vaccine.
She had seizure while driving home; Broken back as a result on an accident after receiving the vaccine; Previously diagnosed with seizure but it had been well controlled with medicine; A spontaneous report  was received from a consumer concerning a 69 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure while driving home and a broken back as a result of an accident after receiving the vaccine.  The patient's medical history was reported as she had previously been diagnosed with a seizure disorder but it had been well controlled with medication. It had been over three to four years since she had a seizure and last time she could remember was in 2017. Concomitant medications taken by the patient were not provided.   On 19 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 023N20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, within about 30 minutes of getting the vaccine she had a seizure while driving home. This led to an vehicular accident and she had to be rushed to the hospital. Her car was totaled and she had a broken back.  Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, Seizure, Spinal fracture , and Condition Worsened, 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, a causal relationship cannot be excluded.
Hep B vaccine administered in Lt Deltoid IM on 3/20/09.  within 24 hiours patient reported left arm and hand numb.  She experienced flu like symptoms with body aches and nausea, no fever.  there was no local reaction, no reddness or swelling at administration site.  symptoms lasted 3 days, and had totally resolved by 3/23/09.
Shaking; Muscle Aches; dizziness, and not being able to get out of bed; not being able to get out of bed; Injection site pain is described as almost the entire arm being in pain; This case was reported by a nurse via call center representative and described the occurrence of tremor in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 hrs 30 min after receiving Shingrix, the patient experienced tremor, muscle pain, dizziness, pain in arm and mobility decreased. On an unknown date, the outcome of the tremor, muscle pain, dizziness, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the tremor, muscle pain, dizziness, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The nurse is also the patient. The age at vaccination was not reported. The patient noted she was in her 60's but did not provide a date of birth. The reporter did not provide a lot number or expiration date for the dose. The patient experienced shaking, muscle aches, dizziness and not being able to get out of bed after dose of Shingrix.  The patient experiences were more severe following dose one. The patient got her dose one at 9:30 and began to experience events at 21:00 the same night.  The following day by 10:00 the events had resolved except for injection site pain. The injection site pain was described as almost the entire arm being in pain for approximately one week following the vaccination.  All events had completely resolved. The follow up to be directed to the reporter's home address. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020196135.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196135:same patient, 2nd dose
Patient was to receive a Moderna BIVALENT booster dose but was mistakenly given Moderna NON-BIVALENT booster dose.
I can't think and I'm having trouble coming up with words; severe brain fog stating "I can't think and I'm having trouble coming up with words, the brain is not working well".; persistent low grade fever; Muscle pain; still is not feeling better; brain is not working well; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 37 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included covid-19 in Feb2020. The patient's concomitant medications were not reported. It was reported that Last Friday a week ago the she had her first vaccine dose and had symptoms that are very severe, including a persistent low-grade fever, muscle pain, and a severe brain fog stating she can't think and having trouble coming up with words, the brain is not working well. She reports that she has been off of work for a week and is unable to afford to see her doctor. She told that she was not feeling better and wants to know if that is normal. She also would like to know if she should get the second vaccine dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm soreness and bruising. Chills and body aches that started about 12 hours after injection (1:00am 04/29/2021). Have been drinking plenty of water (about 100oz daily). Currently (9:45am 04/29/2021) experiencing exhaustion and body aches. No chills, and no other symptoms.
Tested positive for COVID on 22Mar2021; Tested positive for COVID on 22Mar2021; Mild discomfort in throat; Mild discomfort in throat/It was starting to get dry; This is a spontaneous report from two contactable consumer (patient father and patient). This report is to capture information for son. A 20-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6206, Expiration date: 30Jun2021) via intramuscular route in left arm on 16Mar2021 (at the age of 20-year-old) at a 0.3ML single dose, (Lot Number: EN6203, pending clarification) for covid-19 immunization. The patient had no medical history. Concomitant medications were not reported. On 20Mar2021, 4 days after receiving the shot the patient experienced mild discomfort in his throat but had no coughing and was starting to get dry and patient got tested positive for COVID on 22Mar2021. The outcome of the events mild discomfort in throat, it was starting to get dry was recovering and rest of the events was unknown.