chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking does not last as long and as vigorous/feel that my insides are trembling; shaking does not last as long and as vigorous/feel that my insides are trembling; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Feb2021 (Lot number: EN6198) as dose 2, single for covid-19 immunization. Relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "CRPS in Rt. Leg" (unspecified if ongoing), notes: in right leg; "Migraines" (unspecified if ongoing). Concomitant medications included: PROPRANOLOL; LEXAPRO; SIMVASTATIN; COQ10 [UBIDECARENONE]; BABY ASPIRIN. Past drug history included: Clindamycin; Flagell; Amoxicillin. Vaccination history included: BNT162B2 (Dose 1, Lot number: EM9810, Anatomical location: Left arm, Administration time: 11:30 AM), administration date: 06Feb2021, for covid-19 immunization, reactions: "Light sleep" and "shaking vigorously". The following information was reported: TREMOR (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "shaking does not last as long and as vigorous/feel that my insides are trembling". Therapeutic measures were not taken as a result of tremor and disease recurrence.  Additional information: Patient reported that after the first shot, as she turned in the night and was in light sleep, she was awoken because her head, shoulders and arms were shaking vigorously (lasted maybe 10-15 sec). When fully awoke, it stopped. It happened only once. It happened again the next night. After the second shot, it happened again. This time however, it happened several times during the night and has been increasing in the number of times it happens each week. However, the shaking did not last as long and it was not as vigorous, more of a shake-shake- shake. She had begun to feel that her insides were trembling when she woke up. This did pass the more active she become. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425435 Same patient and drug; Different dose and events
headache; nausea; feeling unwell; fatigue; fell in asleep; glucose levels or just doing something else that's causing me to have headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL324U), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of vaccine, and since yesterday the patient have had headache that does not go away with like Ibuprofen and Tylenol. When the patient first got it she was reading on the factsheet that headache, nausea and feeling unwell are some of the symptoms so the patient was getting those and have had some fatigue as well but then she fell in asleep. And this morning, the patient have a headache that goes and come, it's not really, really bad but it's just like it is there and it just bothers her. It was reported that "I was taking Tylenol and Ibuprofen and it really doesn't seem to do anything. I noticed that if I eat something then I will start feeling a little bit better so, I do not know if the vaccine is doing something as far as my glucose levels or just doing something else that's causing me to have headache." The patient received treatment for the events. The outcome of the events was unknown.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for abnormal liver function, cocaine use, ischemic cardiomyopathy, chronic alcoholism, hypertension, bipolar disorder, chronic obstructive lung disease, hyperlipidemia, GERD, CAD, homelessness. Per note 5/5, patient was found deceased in chair on 4/27, cold to the touch and not breathing with no pulse. Immediate cause of death "probably acute myocardial infarction" However no other documentation regarding death confirms this.
Fever, chills, nausea, fatigue, muscle pain throughout whole body,  sore arm, headache and migraines. Worst I have ever felt in my whole life.
Fever, vomiting, chills, fatigue the night after receiving vaccine. Swollen/red/hot leg on Friday.
still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: still sore). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter stated that 5 weeks still sore. The patient getting ready for the second shot.
Pt recv vax on 11/17/98; on 11/18/98 pt exp red vax site w/ warmth; tx=Tylenol, cold compresses
Large red  hard swollen area around and on injection site. Very warm.  Armpit soreness and arm soreness.  Injection site painful. Rash starting around injection site.
1/7/21 Fever, sob, tachycardia, chills, HA, myalgia, photophobia, left shoulder pain, fatigue
pt recvd vax; inconsolable crying for 24 hrs;fever associated but no local redness;WBC=13,100 w/ 50 lymph, 48 gran & no focus on infection;given Motrin & dph;asymptomatic 36 hrs post vax;
Bell's Palsy.  Also occurred with first dose but was not confirmed related to the vaccine until it happened the second time too.
Information has been received from a LPN concerning a few patients who were vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the patients experienced injection site reactions, injection site redness, hotness at injection site, injection site inflammed and pain at the injection site. The patient sought medical attention. Additional information has been requested.
Tightness in chest.  Could not draw a deep breath.  General weakness in legs and arms.
On 02/09/2001 the patient returned to the health center with a mild case, just a few lesions, of chicken pox. It was reported that the patient was treated with acyclovir. Additional information has been requested.
This initial spontaneous report was received from a physician referring to a 3 month-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 03-SEP-2015 at 12:05 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
chest pain; malaise; back pain; never got the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (chest pain), MALAISE (malaise), BACK PAIN (back pain) and PRODUCT DOSE OMISSION ISSUE (never got the second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), MALAISE (malaise), BACK PAIN (back pain) and PRODUCT DOSE OMISSION ISSUE (never got the second dose). At the time of the report, CHEST PAIN (chest pain), MALAISE (malaise) and BACK PAIN (back pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never got the second dose) had resolved.        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.   No concomitant medication were reported.  No treatment information was reported.
3 days after vaccination, site swelled to size of an egg. Two weeks later it is size of quarter.
Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.
pt had recent hospitalization; 8/12/22 pt returned to ED with diffuse pain, hypotension, tachycardia; admitted; 8/23/22 tested positive for COVID; given Remdesivir x3; on RA throughout COVID illness; pt's condition worsened; status epilepticus, hypercalcemia of malignancy, hypokalemia, active malignancy with diffuse metastasis; transferred to inpatient hospice where pt passed away
About 1 hour after receiving the vaccine, patient developed severe body ache and it lasted about 1 week. That worried the patient but she did not go see doctor. She took Ibuprofen and after 1 week, everything is fine.
2nd vaccine kicked off a two-month-long brutal fibro flare causing severe all-over shooting pain and dysesthesia in my feet.  I contacted Covid on August 5, 2021 and immediately the flare ceased.
Covid19 breakthrough.  1st Vaccine received on 08/03/2021.  Pt presents with dementia, bedridden, fever and cough x4-5 days.  Received IV abx/Steroids and Remdesivir.
Muscle pain on and off; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced MYALGIA (Muscle pain on and off). At the time of the report, MYALGIA (Muscle pain on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
TDAP GIVEN 7/11/07.LEFT DELTOID WITH 6 CM ROUND RED WARM ITCHY AREA. NO HX FEVER. HAD 2CM OF HARDNESS NOTED ABOUT THE INJECTION SITE. AREA HAS SOFTENED FROM FIRST SEVERAL DAYS. DR OBSERVED ARE AND ASKED SHE RETURN IN 1 WEEK IF NOT FURTHER RESOLVED.
At the beginning of the injection the needle became detached from the syringe.  Per vaccine manufacturer guidelines, a full dose was repeated in the other arm.
fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (very tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (very tired). On 15-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) and FATIGUE (very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.9 100.9.         Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Followup information was received on 21-May-2021 contains no new information.
Patient vaccinated with first dose of Pfizer at 1:37 pm. Patient walked with his wife over to EMT observation area with steady, balanced gait. Around 1:47 pm, patient became diaphoretic and pale. Patient's wife alerted EMTs of reaction. EMTs responded by transferring patient to anti-gravity chair, placing an ice pack on patient's forehead, and having the patient drink water. Patient states he has a history of fainting and low heart rate. Patient "feeling better" after 15 minutes in anti-gravity chair.
I received my first Pfizer vaccine on 07/11/2021 and on 07/20/2021 I felt swelling in my neck.  It felt a bit like swollen lymph nodes at first but then radiated on all sides of my neck.  I've never really felt anything like it before - a tightness, scratchiness... and at times felt like my throat was sore and could feel a slight pressure/burning in my ears.  The main feeling though was the neck pressure and sensitivity.  Along with these physical symptoms, I felt highly anxious - even though I didn't really mentally feel anxious.  My adrenaline seemed to be running really high.  I went to the doctor on August 2nd and my practitioner felt the swollen neck and asked me to monitor - hoping the swelling would go down.  She ordered blood tests - these came back without sounding alarms.   Unfortunately, the swelling and discomfort in the neck persisted.  My practitioner ordered an ultrasound which took place on September 1st.  The results of the ultrasound showed an enlarged, hyper-vascular thyroid.  She stated it was likely subacute thyroiditis (she mentioned Graves but said more likely the other).  7 1/2 weeks after my vaccination, my neck still bothers me but does seem to be bothering me less than in the beginning.  I am not planning to get the second dose for fear of another inflammatory response like this.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for  29th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
This spontaneous report was received from a pharmacist and refers to a 29 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On unknown dates, (reported as "when she was a child"), the patient received two doses of M-M-R II as vaccination (strengths, doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported). On an unknown date, an unspecified test was performed and showed low titers. The outcome of the patient's antibody test negative and its causal relationship between therapy with M-M-R II were not reported.
Flu; Headache; Sore joints; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Flu), HEADACHE (Headache) and ARTHRALGIA (Sore joints) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced INFLUENZA (Flu), HEADACHE (Headache) and ARTHRALGIA (Sore joints). At the time of the report, INFLUENZA (Flu), HEADACHE (Headache) and ARTHRALGIA (Sore joints) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
shingles; headaches; neuralgia; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Mar2021 in the morning (Batch/Lot number was not reported) at age of 66-years-old as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient experienced shingles on an unspecified date in 2021 with outcome of unknown; headaches and neuralgia on an unspecified date in 2021 with outcome of recovering, all reported as hospitalization. Clinical course reported as follow: The shingles were on the left side of her face and head. She had two bouts of shingles, with other weird things going on. She could not get the second dose of Pfizer Covid Vaccine until she felt well enough to do so, and was past all of the inflammation issues. She thought she had pretty much recovered completely from the shingles; she just has some residuals of headaches which were initially major headaches that have improved, were just mild on and off headaches; and neuralgia from the shingles which has also improved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: metallic taste in mouth, hives/rash on chest, legs, and arms. red and a little itchy
Both eyes started to burn as though i was looking at the sun and could not close my eyelids. Two hours in (around 5:30pm), I could not keep my eyes open. Both eyes teared constantly yet i went through a whole bottle of dry eye relief in 24hrs as well. I went to bed at 9pm and was awoken by the eyes burning at 2am and both eyelids were puffy crusted with discharge. Cleaned eyes and then needed to wet them until 4am. Major burning and tearing reduced gradually across next 4 hours. Dry eye and morning crusting reduced daily and resolved by Sunday, April 11.
Fever 102.9 evening of shot and unable to bear weight on leg for 2 days with redness and swelling for 2 days.  Fussiness for 3 weeks.  No redness or swelling at time of revisit 1/8/08.
MODERNA VACCINE DOSE 1 GIVEN ON 02/05/2021 MODERNA VACCINE DOSE 2 GIVEN ON 03/05/2021 PATIENT ADMITTED TO HOSPITAL 7/12/2021 WITH FEVER, CELLULITIS OF LEFT HAND/THUMB, LEG ULCERS THAT DO NOT APPEAR INFECTED AT TIME OF ADMIT. ON 7/16/2021 PATIENT TESTED FOR COVID TO MEET SNF ADMISSION. COVID ANTIGEN TEST AND PCR TEST BOTH = DETECTED. DUE TO THE POSTIVE RESULT PT REMAINS HOSPITALIZED AT THIS TIME.
Severe itching and hives started and treated with 38 mg Benadryl with little relief then another dose of Benadryl which helped some. I have a biaxin allergy and so does a friend of mine. Found out she had itching and rash too.
The day I received my shot I had a fever and chills 2 hours later. I started my period on Sunday  04/11/2021 and I couldn't stop bleeding . plenty of blood clots and fever. I called my Dr and he  called medicine in and after 3 days the symptoms stopped . I had a Dr appointment on 4/27/2021 and my iron was very low and blood pressure was at stroke level. I go back to the Dr. in 3 weeks for blood work.
The first two days after injection it was painful to lift arm above 30 degrees and hurt upon palpation and I had an overall tiredness. A week after the injection on 1/13/2021 I developed a raised, red rash surrounding the injection site (2in x 4 in). The skin that was inflamed was 101.2 degrees fahrenheit.  The intense rash lasted around 24 hours and subsided after 3 treatments of Benadryl cream and one dose of oral Benadryl. The skin is still slightly raised and has a slight redness to it today (1/15/2021) but is much better than before.
Tested NAAT positive for COVID 11/12/21 after being fully vaccinated.
Onset of a slight cough and throat tickling at 10:20. Zyrtec was given at 10:25. Had worsening syptoms with complaints of throat tightening.  O2 98% Pulse 90.  Increased cough, Epi given at 10:30.  Went to ED and received racemic Epi Neb, Benadryl 50 mg and dexamethasone 10mg, Pepcid at 10:35.  Worsening throat tightening  2nd Epi was given 10:40. Increase difficulty speaking, 02 sats briefly in the 80-85%, RSI was made after discussion with patient.  Rash developing on upper chest and neck.  Pt required intubation at 10:43. Patient was RSI's successfully with a 7.5 ET tube, 21 inches at the teeth.  Breath sounds were noted.  3rd dose of Epi given 10:45.
Patient initially registered a fever on11/2, patient had low O2 on 11/3 and had to be sent out via 9-11 as O2 could not be efficiently sustained here. Patient passed in the hospital on 11/3 at night due to "heart attack"
lt hip had 10x8 cm induration;not necessarily inflamed but questionable, therefore, pt was treated w/med;
Cellulitis at injection site; mom called office on 9/24/13 to report. Pt was instructed to come in and be seen. ROCEPHIN 500mg IM injection was given. Rechecked 9/25/13 and redness and tenderness was much better.