chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day).  I began to feel weak and tired; all I wanted to do was lay down.  I laid in bed and took my temperature via ear.  100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age).  I was also experiencing a headache (back of head) and neck discomfort.  I felt hot, specifically ears and face.  I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm.  by 10:30 my temp was 98.9.  I woke up at 1:30am on 4/17/21 and was completely drenched I sweat.  I assumed this was from the fever break but I woke up again at approximately 4am drenched again.  After waking and getting up around 8am on 4/17/21, I felt great; back to normal.  I went about my day.  I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position).  When I sat up, I felt some sore, throbbing on the top of my head which then subsided.  I woke again at 4:30am with the same issue.  I was also, again, completely drenched in sweat but no fever this time that I am aware of.  My pajamas were soaked.  I felt some relief with the head and neck discomfort when I got up at 6;30am.  As I type this now, my head and neck feel basically normal.  I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm.  It runs down my left side from my arm pit to the side of my left breast.  This area has been sore and tender since the evening of the day I received the shot (4/15/21).  I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.
1/7/2021: 1200 PM  H/A 1700 - 1100 PM  Chills with continued shaking 1100  PM Febrile 102.5 1100 PM Swollen/Painful lymph nodes -left axilla
This case was reported by a healthcare professional, via another manufacturer (Merck) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (details unknown). Three days after vaccination with KINRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
I experienced a large, itchy rash covering my upper left arm near the site of the first vaccine injection. The rash appeared appropriately 3 days after being vaccinated with the first dose. The rash lasted for approximately 2 weeks before subsiding.
Itchiness in neck, face and scalp; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 21:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (NEURONTIN) and alprazolam (XANAX), both were taken for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced itchiness in neck, face and scalp. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of itchiness in neck, face and scalp was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had a rash on left arm next day late evening, asked mom to give benadryl This helped  , rash is gone completely.  MOm had applied ice on the arm
Appears vaccines in both arms may have been administered too high on the upper arm. Pt not complaining/reports bilateral upper arm and shoulder pain.
No additional AE; patient was inadvertently administered VARIVAX and MMRII via intramuscular route as opposed to recommended subcutaneous route; This spontaneous report was received from physician and refers to a 15-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated with dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T032318, expiration date: 22-SEP-2022, administered intramuscularly for prophylaxis (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U014656, expiration date: 07-MAY-2023, administered intramuscularly for prophylaxis (strength was not provided) (incorrect route of product administration).  No additional adverse event was reported.
This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, relevant past drug history and concomitant medications were unknown. On 12-JUL-2018, also reported as "10 days ago in July 2018", the patient received an unknown dose of VARIVAX for prophylaxis (strength and route of administration were not provided, and lot # and expiration date could not be requested). On 22-JUL-2018, the patient called stating she got chicken pox (varicella). Relevant laboratory data was unknown. It was unknown if the patient would got VARIVAX again. Additionally, it was unknown if the physician was also the prescriber. At the reporting time, the chicken pox continued. The causality assessment between the aforementioned adverse event and VARIVAX was not provided.
Information has been received from a woman working in a physician's office concerning an 18 month old white male with hemophilia, a hematoma on his forehead, and who had underlying allergies, who on 08/23/2005 was vaccinated with a firs subcutaneous dose in the right thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot # 649239/0030R). Concomitant therapy included factor VIII, which he had in the last week due to the hematoma on his forehead. It was reported that the patient has had cold symptoms "for about two weeks", since approximately 08/23/05, and developed a rash "yesterday", on 09/01/05. the rash was non-itchy, and he had no fever. It was reported that he has acted fine, not fussy. The patient was alert and calm. Appeared in on distress. He had a viral-appearing exanthem with small reddish/pink, maculopapular lesions scattered over his trunk, with some on his shoulders and proximal extremities. There were no petechiae or vesicles or urticarial lesions. He was moderately congested, and had allergic shiners and Dennie's lines. He had a clear rhinorrhea. There was a small resolving bruise on his forehead. His chest was clear, cardiac was unremarkable, abdomen was benign, joints appeared normal and he moved with obvious discomfort. It was reported that the diagnosis was a rash, probably a measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live reaction, and had underlying allergies. It was not that diphenhydramine tannate (Dytan) suspension was sampled, 1/4 teaspoon, every 12 hours. It was noted that the rash was expected to dissipate, and the patient was to call if there was worsening or new symptoms, swelling of the joints or others. Additional information has been requested.
tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LOSARTAN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive after vaccination, this event is assessed as unlikely related to mRNA-1273.
The patient got dizzy and hot after getting the vaccine. Sitting up at 2:03 pm with sitting the patient still feeling a little dizzy after sitting for a little the patient was feeling better. Patient was walking with no problem and just washed out feeling
CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.
In June of 2021 I had extensive blood work done none of this showed cancer in my genetic make up. I also had an extensive CAT scan and it did not show any genetic markers for cancer. In November I had I a mammogram that showed a pea size lump that looked like a swollen lymph node. In February I went in and I was diagnosed with a Stage III plus breast cancer. The chemo and radiation is not working and will have to have a double mastectomy.
I received the Tdap vaccine on 03/06/2014 as a requirement for work.  Within hours I had pain in the left shoulder where I received the vaccine.  I had anticipated being sore and thus requested that the shot be given on the left side in my non-dominant arm.  Tenderness was greater than anticipated but by the next morning had progressed to excruciating pain.  In addition, I had flu like symptoms with whole body aches and joint pain.  I took 400mg ibuprofen twice with only minimal improvement of symptoms.  I felt feverish and tympanic membrane temperature was 100.5 F.  This was after having taken Motrin about an hour prior so Tmax is unknown.  The alarming symptom was the excruciating 8/10 pain in left arm.  I have limited range of motion on that side d/t both pain and weakness.  I cannot raise the left arm greater than 30 degrees in any direction and if I try to I get pain that radiates up my neck and down the ulnar side of my arm.  I have pain from the slightest bump to my body which is nearly unbearable and I am completely unable to lay on that side, use it for support or pick my son up with the left arm.  This is both scary and concerning as I am an ICU nurse and will not be able to fulfill all the requirements of my job if this persists.
c/o sob, stomach upset,  lightheadedness, diarrhea and fatigue, onset 3/8/21.  dose 1 Pfizer Covid vaccine given at a medical center 3/4/21, denies any anaphylactic type  reactions immediately post vaccination.  Reports the fatigue was so severe that he almost fell asleep while driving and  "almost had an accident".  He  had a negative covid-19 test at the medical center on 3/10/21, however his sx persisted  especially the feeling of sob and lightheadedness so he presented to   ED for eval on 3/15/21 where he had another negative covid test. He received  fluids  and a CXray was done and negative. His home O2 sat has been 94% and HR  75. Hedneis any ahx of asthma or lung disease.  The fatigue has subsided today but can be intermittent and random, yesterday  he  had 3 episodes of sob intermittently w/o wheezing or  chest pain. he denies loss  of taste or smell, the lightheadedness has subsided today.
Sore arm; Injection site swelling; redness at injection site; injection site itching,delayed; Injection site hard bump,delayed; Injection site swelling,delayed; Injection site redness,delayed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (injection site itching,delayed) and VACCINATION SITE INDURATION (Injection site hard bump,delayed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching,delayed), VACCINATION SITE INDURATION (Injection site hard bump,delayed), VACCINATION SITE SWELLING (Injection site swelling,delayed) and VACCINATION SITE ERYTHEMA (Injection site redness,delayed). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (injection site itching,delayed), VACCINATION SITE INDURATION (Injection site hard bump,delayed), VACCINATION SITE SWELLING (Injection site swelling,delayed) and VACCINATION SITE ERYTHEMA (Injection site redness,delayed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 WRONG PRODUCT ADMINISTERED (Patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 12th of 18th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Severe pain leading to decreased motion and inability to use arm in which vaccine was administered. Pain began one day after injection and continues one week after.
Administered vaccine at approximately 1:15PM. Monitored for 15 minutes. No reaction noted. Patient went back to the floor to complete her duties. Came back to the clinic around 3:00PM with noted lip swelling, skin rash. Clinic physician on site ordered Benadryl X2, IM Solumedrol. Also ordered to send patient home with a Medrol dose pack which was provided. Patient was sent home from work and a family member came to get her. Patient was instructed to call 911 for any further reactions. Vitals at time of reaction were: Pulse 96bpm, O2 99% on room air, BP 155/90, lungs clear.
Nose irritation/irritation in the nose; Runny nose; Itchy eyes; typical allergy reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP)from medical information team. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 15:00 (Lot number: EW0191) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal Allergy" (unspecified if ongoing), notes: every spring he had several weeks of this kind of allergy attack; "Increase in weight" (unspecified if ongoing), notes: he has an increase in weight in but this was before the last dose, it started more than a year this has been going. Concomitant medication(s) included: FUROSEMIDE taken for swelling, stop date: Sep2021. Vaccination history included: Bnt162b2 (Dose:01, Anatomical location; left arm, Lot number: EK9231), administration date: 26Jan2021, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "Joint swelling", "Peripheral swelling"; Bnt162b2 (Dose:02, Anatomical location; left arm, Lot number: EL9266), administration date: 16Feb2021, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "Joint swelling", "Peripheral swelling". The following information was reported: NASAL DISCOMFORT (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Nose irritation/irritation in the nose"; RHINORRHOEA (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Runny nose"; EYE PRURITUS (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Itchy eyes"; HYPERSENSITIVITY (non-serious) with onset 23Sep2021, outcome "not recovered", described as "typical allergy reaction". Therapeutic measures were taken as a result of nasal discomfort, rhinorrhoea, eye pruritus, hypersensitivity.  Additional information: Other Products, Patient History and Investigation Assessment mentioned as No. He notes that he is not sure if it started the evening of the booster shot but it was definitely there by the next morning. This is why he is not sure about the connections with the event or the vaccine. Patient was not visited emergency room and physician office. The patient did not receive any other vaccine in four weeks. He has an increase in weight in but this was before the last dose, it started more than a year this has been going. Every spring he had several weeks of this kind of allergy attack. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101293536 similar report from same reporter
pt states he did not sleep well the night after taking the vax and when he got up next morning he was very dizzy and nauseated.   He had to hold on to furniture to get to the restroom and then vomited.  He feels like he is having a vertigo episode.  He is also urinating a lot more than usual and has a pain in his kidneys.  Pt has contacted his PCP but they not have returned his call yet.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 01-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Patient checked no on are you currently pregnant question on immunization screening form and did not notify RN that had a positive at home pregnancy test until after the shot was given. RN reviewed information on vaccine and that next dose should not be given until no longer pregnant.
1/27/21 fever 100.3 with Motrin, headache, joints pain
first dose of Shingrix 7 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 7 months ago on 22nd May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a 13 years old female patient. The patient had no pertinent medical history, no drug reactions/allergies. On 25-AUG-2011 the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot # 0102AA as reported expiry date: 12-JAN-2013) (location unspecified, subcutaneous). No concomitant medication was reported. On 06-DEC-2013, the patient was scheduled to be evaluated in the office for possible shingles. The patient's mother called the office and forwarded a picture of the rash to the physician. The physician stated that the rash on the right arm appeared to be red with popular-vesicular lesions that follow a dermatone distribution on 05-DEC-2013. No treatment was given for the events. The patient had sought medical attention via patient's mother called office. No lab diagnostics studies performed. At the time of report, the outcome of the shingles was not recovered. Additional information has been requested.
Moderna (6m-4yr) vial was pulled from the Refrigerator 8/15/22 at 0745, Lot # AS1414B.  At around 1200 it was noticed that the vaccine BUD date was 8/12/22 and it should have been discarded on 8/12/22.  There were two doses given from this vial, patient being one of the patients. The incident was reported to Moderna and I was told we would be getting notification in 3 days in regards to the stability of the vaccine given and the next steps to take.