chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEEL STRONG IN THE MORNING; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergy to chloroquine (difficulty sleeping, itching, fast heartbeat). The patient experienced drug allergy when treated with chloroquine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 04-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 17-MAY-2021, the subject experienced difficulty sleeping. On 18-MAY-2021, the subject experienced feel strong in the morning. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, and the outcome of feel strong in the morning was not reported. This report was non-serious.
dizziness; weakness; constipation; A spontaneous report was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, weakness, constipation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) dizziness. weakness, constipation.  Treatment details included laxative.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) dizziness was considered resolved on 10 Feb 2021.The outcome of event(s) weakness was considered resolved on 10 Feb 2021. The outcome of event(s), constipation,  was unknown.
15 minutes after the Moderna vaccination was given, the patient complained of nausea and feeling faint.  He then fainted for about 2 minutes before regaining consciousness. The Paramedics showed up and said he was okay.  he patient was feeling better after 10 minutes and went home with a family member after being checked out by the paramedics
Fatigue, felt drained for 4-5 days; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FATIGUE (Fatigue, felt drained for 4-5 days), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD-2021-103247 (Patient Link).
Normal soreness at the vaccine site for 2 days after vaccine was administered on 3/16/21.  On 3/25/21 Symptoms started with joint pain in the left arm. Muscle soreness. Red rash with heat at vaccination site about 2 inch in diameter. Daily the diameter increases by an inch. Today 3/29/21 it is ~7-8inch in diameter. Entire red area is very swollen.
After receiving the second dose in the serious I woke up the next morning to heavy vaginal bleeding. I was not due for my menstrual cycle so this was surprising. Since then I have had extremely bad cramping and bleeding. I am not pregnant, I don?t have any gynecological disorders and I usually don?t have cramping this bad. It has been 3 days of this so far. Then approximately 24 hours after the vaccination I became severely fatigued. So for the last 3 days I have been unable to work due to this pain and fatigue that makes me feel incredibly weak.
This patient was given the vaccine at an off-site clinic event and received the Janssen vaccine which in indicated for patients 18yr and older however patient is 17 years old. Advised father and patient of incident, no reported side effects or adverse events as of time of communication with patient.
sore arm; swollen arm; fever 100; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (swollen arm) and PYREXIA (fever 100) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (swollen arm) and PYREXIA (fever 100). On 21-Apr-2021, PYREXIA (fever 100) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (swollen arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100 (High) 100.         No relevant concomitant product were reported  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Through quality checks it was discovered that the patient likely did not receive a full dose. Patient notified that it is recommended that they are re-vaccinated. Patient returned for repeat dose on 12/1/21.
This case was reported by a nurse and described the occurrence of injection site cellulitis in an 18 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 19Feb2004 the pt received the fourth dose of Infanrix. The day after receiving Infanrix, on 20Feb2004, the pt experienced injection site cellulitis. The pt was treated with unspecified antibiotic therapy and the event improved. The nurse considered that the event was possibly related to vaccination with Infanrix.
Low grade temp; body aches; fatigue; joint pain; This is a spontaneous report from a contactable consumer (reported for herself). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6201/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 13Feb2021 at 10:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunisation at Health Clinic. The patient medical history included hypersensitivity from an unknown date and unknown if ongoing and other medications was received. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Feb2021 at 16:00, the patient experienced low grade temp, body aches, fatigue and joint pain. The patient underwent lab tests and procedures which included body temperature: low grade temp on 13Feb2021. No treatment was given for the events. The outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
pain in the right arm; having pain in the right arm that shoots up to her neck; pain affects her ability to sleep at night; decreases her range of motion when reaching backwards with the right arm /unable to left heavy things; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, immediately after receiving Shingrix, the patient experienced pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved and the outcome of the difficulty sleeping and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain in arm, neck pain, difficulty sleeping and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and immediately started having pain in the right arm that shoots up to her neck.  The reporter states this pain affects her ability to sleep at night, decreases her range of motion when reaching backwards with the right arm and she was unable to left heavy things.  The pain had constant since dose 1 and had not resolved at this time.  On 14th October 2019, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, mobility decreased and activities of daily living impaired.  The follow up consent was granted.
Headache for approx 15 hrs after injection.  Followed by tiredness,  sore throat,  dizziness,  and nausea. Headache went away with advil, other side effects continue to the time of this submission.
MIGRAINE; STRONG UTERUS CRAMP; COULDN'T MOVE; BURNING EYES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bilateral mastectomy, and concurrent conditions included penicillin and aspirin allergy, and breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, strong uterus cramp, couldn't move, and burning eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong uterus cramp, migraine, burning eyes and couldn't move was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Initial misuse report received from a health care professional on 16 October 2013.  The cases were received at GPV on 21 March 2014. It was reported FLUZONE was given to 10 patients over 65 years of age. No adverse event was reported. List of documents held by sender: none
7/10/09 Pt. presented to doctor with (R)axillary swelling. Area felt boggy. No warmth or redness.
After second dose, rashes in addition to itchiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Currently asthmatic" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ANTIHISTAMINE ALLERGY RELIEF; SYMBICORT. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right), administration date: 04Aug2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "Itchiness occurred on right side of body for a couple of days after first dose". The following information was reported: RASH PRURITIC (non-serious) with onset 2021, outcome "not recovered", described as "After second dose, rashes in addition to itchiness". Therapeutic measures were not taken as a result of rash pruritic.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications Vitamins within 2 weeks of vaccination. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   Follow-up attempts completed. No further information is expected.
Increased T /p noon of administration. T 100.6, Wed 16Jan increased T up to 101, anorexic. Thurs 17Jan 730 am T 100. 1030 am T 103, listless & lethargic, slow response to stimuli. Sunday Dr seen, Dx: rxn to DTP no treatment until 21Jan
Heart flutters, rapid beating for at least 2 - 3 days in the past week
Caller was belligerent stating his arm began to get sore after he received the vaccine on 1/19/21 now he "cannot move his arm". Seeing his PMD. He asks if he can apply cold or hot compresses. Advised him he can try warm compresses but at this point it hw needs to be evaluated by a Dr. Caller is angry and hangs up since no "home remedies" No info obtained since he hung up, no caller ID available since he was transferred to this line.
- Injection site pain lasting for four days, on first two days pain was severe, on the third day the pain was moderate, and on the fourth day was mild.  - Body weakness/fatigue for the first two days.  - Chills with diaphoresis on first two days.  - Elevated body temperature, but no fever on first two days.
Right leg, calf, pain, moderate, persistent, extending upwards, preceded about 24 hours by cramp, same region.
I have horrible ringing buzzingin my ears. Started first with buzzing in ears just at night for about two weeks. After two weeks it is all the time buzzing. Seems to be louder in the evening and night. It is causing anxiety.
patient states in just a few minutes he began to have muscle and joint pain throughout his body. Within approx 20 minutes he "felt extreme muscle pain and feverish" for approx. 3-4 hours and then symptoms began to subside.  He stated he felt better the next day.  He does have fibromyalgia and said he is never completely free from discomfort, but had never felt like this.  He did not take any medications to relieve the pain or fever because he was afraid he would "mask his symptoms".  He did take his regular medications at 9:00 pm.  Patient is from Oregon and just visiting in Montana until end of September.
Pt recvd HIB on 01APR91; Subsequent to administering the vax, it was noted that the vax was beyond its expiration date; @ time of report, no adverse exp noted;
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 11-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
Feeling of a lump, burning or irritation under left arm, pulling feeling when arm is in a relaxed position; No treatment has occurred  Experiencing symptoms for over three months with no resolution
Itching at injection site starting around 2 hours after vaccination. Pain along lymph nodes in left side. 5/14 awoke to intense itching and approx 2? in diameter eased warm welt on top of  tennis ball size knot at injection site. Also included is pain in major joints.
As per employee's self-reporting on 10/12/10: slight itching began at 4pm on 10/7/10; weakness and joint pain began at 8pm on 10/7/10; sweating began at 8am on 10/8/10; by 2am on 10/9/10 he had sweating, a rash, and joint pain; itching became extreme by 8am 10/9/10 through 10/10/10.
Per spouse, patient was beginning to experience symptoms of runny nose, sore throat, muscle aches, pink eye, and fever several hours in the evening on the day of vaccination.  Patient saw his physician approx. 1 week after the vaccination for ear infection.
Received vaccine on 7/13/22 and started to have muscle pain on left arm next day and still has pain on arm (reported day 8/4/22).  Patient actually said pain is getting worse.
Patient noticed swelling and itchiness mostly on face on morning of April 1, 2013. She continued to feel itchy and swollen mostly on face (less throughout body) through Tuesday April 2, 2013. She took 2 doses of Benadryl tablets on Tuesday evening of April 2, 2013. She took 1 tablet around 6:30 pm and another dose later in the evening. She felt some relief by Wednesday morning April 3, 2013. Patient reported some itchiness of legs/feet on Wednesday morning April 3, 2013. By Wednesday evening at 7:30 PM on April 3, 2013 she reports that symptoms have completely resolved and she is okay.
sharp pain in the middle of her chest; feeling fatigue; sore throat; achiness in her arm and back; This is a spontaneous report from a contactable consumer reported for daughter (patient) that: A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Apr2021as DOSE 1, SINGLE for COVID-19 immunization.On an unspecified date the patient experienced sharp pain in the middle of her chest, feeling fatigue, sore throat and achiness in her arm and back. It was reported that Patient received her second dose of the Pfizer-BioNTech COVID-19 vaccine yesterday and experienced a sharp pain in the middle of her chest about 10 minutes ago. She asked her daughter to join the line and her daughter added she has been feeling fatigue, a sore throat, achiness in her arm and back. Her daughter also described the pain on her chest as shooting pain at first which lasted between 10-15 minutes and now it feels more like a tightness with sharp pain here and there. They asked if chest pain were reported as side effect from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 15 month old pt who on 1/10/2002 was vaccinated with MMR II (lot 639619/0594L). On 1/17/02, the pt developed a low-grade fever. On 1/21/02, the pt presented to the physician's office with a widespread mealses-like rash all over the body. The nurse requested a lot check of lot 639619/0549L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was released. The nurse reported that another pt developed a fever and a measles-like rash post vaccination with MMR II (see WAES0202USA01822). Additional info has been requested.  Reported on 06/04/2003: "Follow-up information received indicated that the patient was "fine now".  No further information is available.
Development of Arthritic Conditions: Bilateral pain in both heels beginning 1/17/23 (no injury prior to pain).  Pain worsened 1/20/23 and continued to worsen every day and moved to ankles/feet.  Extreme swelling occurred in both ankles.  Saw a podiatrist on 1/24/2023 - had xrays and bone scans of both feet/ankles - both negative.  Saw podiatrist again on 1/31/2023 - ordered blood work to check for arthritic conditions/rheumatoid arthritis.  Pain/joint stiffness developed in knees, wrists, and elbows beginning 2/2/2023.    Started Medrol Dosepak treatment on Friday 2/3/2023.
Noticed hives at injection site of dtap, left thigh. Area swelling and hot to touch. Given 25 mg of benadryl and notification clinic of reactio, 1:15 pm. Hives subsided with benadryl but 2 hours later they reappeared. complained of her head hurting a lot and stomach pain. RN from clinic called and I gave her further information, no treatment advice given. Area marked with pen to watch for spreading, given another 25 mg dose of benadryl and added 10 mg claritin before bed, 8 pm. Also given 4 mg zofran for nausea as she complained she felt very sick.  This morning she complains of stomach pains and the hives have spread past the pen markings. Swelling still present and bruising at injection site.
pt had 5-6hr of inconsolable, incessant crying & red swelling of rt thigh
Phone call from mom this a.m. Left deltoid swollen tender. Red yesterday. upon inspection small bruise resolving 2" below inject site. Area from near shot site softer at edges.
This spontaneous report as received from a health care professional refers to unspecified patients of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, 3 doses of improperly stored VARIVAX (lot # K009759, expiry date: 09-JUL-2016) were administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
My Mom the next day, Saturday 3/20/22 had short term memory loss for a couple of hours.  My parents drove to the grocery store on Saturday afternoon.  After a few hours at the grocery store, my Dad went outside to the car and waited for my Mom while she pays for their groceries.  After waiting an hour, my Mom still hasn't come out so my Dad called her.  She told my Dad that she has no idea where she is.  My Dad went back to check on her and she said that she has no memory of her putting items in the car or talking to their friends earlier.  My Dad took her home to get some rest.  After a couple of hours, my Mom is still experiencing short term memory of not knowing what happen earlier as she kept going back to the car to check on their groceries, she kept saying "its 6 pm? where has the time gone", and she kept saying am I going crazy I can't remember what happen.  My Dad and their friends verified these events happen while she has no idea.  We told her to  just get a good night of sleep that night.  The next morning, she was feeling better and coherent remembering what happen last night and during the day but she still can't remember what happen in the few hours they were at the grocery store.  Today 2 days later, March 22 she is back to normal.
The 2nd dose of moderna vaccine in the series was given at day 21 instead of day 28 +/- 4 days per protocol. The patient has no adverse reactions or issues. The pharmacy manager reached out to the patient to explain the situation, explained that no extra dose is indicated and the patient expressed understanding and no issues.