chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ache; fever(101.2 F); felt without energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), PYREXIA (fever(101.2 F)) and FATIGUE (felt without energy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (ache), PYREXIA (fever(101.2 F)) and FATIGUE (felt without energy). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 03-Feb-2021 for Fever, at a dose of UNK dosage form. At the time of the report, PAIN (ache), PYREXIA (fever(101.2 F)) and FATIGUE (felt without energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101.2 f (Inconclusive) 101.2 Fahrenheit.         Concomitant products included blood thinner medicine and cholesterol medicine.
very sick for many days; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or other non professional via social media.  This case involves an adult patient (age and gender unspecified) who become very sick for many days (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor. Past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, in 1976, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very sick for many days (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that, in the same year of vaccination, some ended up with paralysis but reporter was fortunate.  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome for reported event was unknown.  There will be no information available on the batch number for this case.
asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across her chest; rapid heartbeat; nausea; tightness in her throat; she couldn't breathe; Asthma attacks; There were a couple nights where she was wide awake for 24 hrs; She is being treated for a severe allergic reaction; her throat was paralyzed; she couldn't swallow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EM9809) as 0.3ML single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that the initial thing was about 30 minutes after the vaccine and she couldn't swallow, her throat was paralyzed. She was at the hospital for 4 hours. She had nausea and covid symptoms and tightness in her throat but it was not super severe. It didn't feel like she couldn't breathe. There were a couple nights where she was wide awake for 24 hrs. She stated at first it was manageable but as time went on it started getting stronger. She stated she had seen a doctor about this. The patient had the second dose of the vaccine on 13mar2021 and since then had been having asthma-like conditions. She was being treated for a severe allergic reaction. The patient has had tightness in her chest, kind of tingling in her shoulders and right arm and across her chest. She had a rapid heartbeat which she had no control over and it comes on and goes away. She was trying to see if there was a pattern but in the morning she had the sharp hot things through shoulder and back and that brings on tightness in her chest and then asthma and this follows the same pattern every 3 days. She stated she had 2 days of nothing and then the night before [before the third day] she had a rapid heartbeat and the next morning had the hot tingling things, and then an asthma attack. She asked what it is that she might be having an allergic reaction to? The patient stated she already had a list of ingredients. She stated she will reach out to her doctor to discuss this further. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Coughing congestion,nose,chest ears runny nosy stuffy nose  sore throat body pain fatigue muscle aches 5/26/21 - now
Broke out in hives all over his body.  Gave him Aveeno-oatmeal baths and Benadryl and Calomine lotion for itching.  Recently diagnosed with Autism.  Hot patch where shot was administered.
Left upper arm swelling redness and pain X 3 days. Resolved after 3 days with ICE.
Pt recvd 3 doses of Engerix-B 10MAY91, 6JUN91 & 12NOV91 (?11NOV91) & 11NOV91 immed p/3rd dose of vax exp burning while inject was being given which cont for a few hrs;
COULD NOT USE ARM WHERE VACCINATED. HIGH LEVEL OF PAIN. ICING AND ADVIL ON 4/8/2017 PROVIDED MINOR RELIEF. BY 4/10, USE OF ARM IMPROVED WITH MUCH LESS PAIN.
Mom reported "she had hives starting about 18 hours after her shots" "more like welts" "The hives lasted 2 1/2 days" "She used oral BENADRYL and topical BENADRYL" Denies any previous reaction to vaccinations, denies medication or other known allergies.
Per patient; "almost instantly" after receiving 1st Moderna vaccine she felt warmth go up entire body, felt heart was beating fast, and felt tongue was swollen. She was given 10mg Cetirizine sublingual. Symptoms resolved after 15 minutes. No visible tongue swelling. Vitals signs were stable throughout assessment.
1/17/2021  2:00pm Vaccine administered, abiding by the CDC and ADH guidelines for safe distancing and masks. Looked at injection site and it looked normal, just a little red dot where the needle was directed to administer the vaccine. 7:00pm arm started to itch at injection site. Looked at site and it was a large red spot, warm to touch and had a large knot under the red injection site. Itching continued through the night isolated primarily to my upper extremities (arms, chest, face) region. Did not take Xyzal that night for fear of some type of interaction.  1/18/2021  6:00am awoke to more facial itching and took a shower. Noticed red splotches in the T zone of the face. More isolated around my eye lids, a section on my forehead, on the right side of the bridge of my nose, and my laugh lines on my face from the bottom of the nostrils down both sides of my mouth to my chin. Arm was sore, which I had expected and the spot was more red than the previous day, still warm to touch, and knot was still present.  7:30am Got to work and my took a 1/2 tablet of Xyzal since I can't function on a whole dose of that or Benadryl for a work day.  Itching subsided for about 4 hours.  1:00pm Took another 1/2 tablet of Xyzal. Lasted another 4 hours. 6:00pm Itching was back bad enough I took my normal nightly dose of 1 Xyzal table. It seemed to help until morning. Massaged knot on arm and tried to help lessen the soreness of the area. It was tender to touch, but not painful. 1/19/2021  5:30am Awoke to itching, spot still red, knot gone down compared to previous day. Took shower. Noticed that heat seems to bring out the redness in my face and makes the itching start again. Hot showers were not helping apparently.  7:00am Took 1/2 Xyzal, since itching was continuing. Lasted again for about 4 hours. 12:00pm Took 1/2 Xyzal and lasted an additional 4 hours. Thought the itching should be going away. 6:30pm Took normal dosage of Xyzal. Knot still present but not as prominent as previous days. Injection site still red.  1/20/2021 7:30am Went to local PCP for medical opinion and assistance. He gave me a steroid shot and gave me a Prednisne DosPak with a total of 21 steroid tablets to start administering  on 1/21/2021. Was advised to not take the second booster of the Moderna Vaccine and to see advice as to the recommend course for vaccination of Covid-19  since I had an allergic reaction to the vaccine.
6 hours post vaccine, experienced fever, chills, body/muscle aches, fatigue, "brain fog" and runny nose.  Self treated with Tylenol, rest, fluids, Gatorade. Symptoms lasted 5 full days, missed work x 2 days.  Fully recovered by 1/27/21.
extreme dizziness; weakness; I am sick; I am almost dying here; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here). At the time of the report, DIZZINESS (extreme dizziness), ASTHENIA (weakness), ILLNESS (I am sick) and FEELING ABNORMAL (I am almost dying here) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.   Reporter did not allow further contact
Oct 7, from 6p: chills, body aches, headache, heartburn Oct 8, from 4am: swollen lips, tongue and throat Oct 8, from 6am: airway narrowing/difficulty breathing Oct 8, 7am at the ER: treated with epinephrine and a steroid injection. All symptoms listed above PLUS pins and needles all over Oct 8, release from ER at 10.30am: benadryl, hydrocodone Oct 8, 3pm, symptoms still present but less severe
Erythema, warmth, edema, pain extending from shoulder to Elbow (Left arm) Dx: Cellulitis; Treated with Clindamycin 300mg PO QID. Ice packs to site.
Irregular menstral cycle . Period came on time then again two weeks later with brown versus red blood and cramps
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 16th March 2018, the patient received SHINGRIX .5 ml. On 21st March 2018, 5 days after receiving SHINGRIX, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved. The reporter considered the injection site rash and injection site itching to be possibly related to SHINGRIX. Additional information was received as follows: The pharmacist reported that a patient received SHINGRIX on a Friday and started having symptoms on Wednesday. No other vaccines given on the same day.
Soreness at the point of injection; loose stool; slight rapid heartbeat/pulse but then back to normal.
large Red Injection Site; Warm to the touch Injection Site; Tender to the touch Injection Site; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-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 PAIN IN EXTREMITY (Sore Arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site). On 29-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: numbness and tingling in the left arm since the second dose.  it comes and goes and she has not seen a doctor regarding this yet.  She does have some relief when taking alleve.  counseled to try alleve for a few days straight and then follow up with md if not resolved.  Counseled may be temporary or possibly permanent
Apon review of chart.  Nurse mistakenly gave proquad instead of MMR.
AFTER PATIENT RECEIVED VACCINAITON, PATIENT BECAME PALE, LIGHT HEADED AND QUEASY. PATIENT DID DRY HEAVE, BUT EMISIS DID NOT OCCUR. PATIENT WAS MONITORED FOR AN ADDITIONAL 15 MINUTES, UNTIL SYMPTOMS SUBSIDED.
INCREASED SALIVATION; HARD TIME SWALLOWING FOR A  MINUTE; TINGLING FACE; WEAKNESS; BOTH ARMS ARE VERY SORE; NAUSEA; VOMITING; FLUSHED; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 19:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced tingling face. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced both arms are very sore. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021 19:00, the subject experienced hard time swallowing for a minute. On 08-APR-2021 19:10, the subject experienced increased salivation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased salivation on APR-2021, and hard time swallowing for a minute on 08-APR-2021, and had not recovered from flushed, vomiting, tingling face, weakness, nausea, and both arms are very sore. This report was non-serious.
No adverse event; BUD was reported as 12-May-2021 and vaccine was administered on 16-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12-May-2021 and vaccine was administered on 16-May-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12-May-2021 and vaccine was administered on 16-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12-May-2021 and vaccine was administered on 16-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD was reported as 12-May-2021 and vaccine was administered on 16-May-2022).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains additional no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Vaccine administered without diluent. This was noticed the next patient that came in. We immediately called Pfizer  and looked at the protocol. We called the patient's mom and let her know the guidelines are to monitor for increased side effects and contact health professionals if needed.
her arm is still swollen and hurting; her arm is still swollen and hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "her arm is still swollen and hurting". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Both vaccines given in same arm per pt request. Pt had immediate pain after PNEUMOVAX. She had to pull over on interstate. Pt arm was swollen and unable to move/raise arm. Pt blacked out on 12/05 and went to ER. Was tested for blood clot - test negative. Was given NSAID/muscle rel. and steroid. Pt said gained 7 lbs in fluid weight. Pt went to pain mgmt. MD and got a steroid shot on 12/06. Pt also had a fever on 12/2 or 12/3.
Patient received a dose of vaccine that may be less than fully effective due to storage at room temperature for more than 12 hours
(L) deltoid area around injection 1 1/2" wide x 1" long slightly raised, very warm, and red.
Pain, redness, swelling at injection site. Advised ice at site BID and Keflex x 5 days
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series) on 05/07/21. Hospitalized from 08/07/21 - 08/23/21. Below is copied from discharge (death ) summary:
I received the shot at 10am 4 /30 and by 930pm I started getting chills.  I was so cold i had 3 blankets and could not get get warm. My teeth were chattering. So cold I felt like I was in a freezer. Then by 1030pm my fever was 101.1.  I took 2 Tylenol and went to bed.  Woke up at 1am fever was 103. Took 2 ibuprofen.   I was still cold but not shaking. Woke back up at 6 am fever was 103.5.  Took 2 more ibuprofen.  Woke up at 9am fever was down 101.5.  Took 2 Tylenol.  By noon fever was gone.  I felt much better but was exhausted.  Took a nap. Woke back up at 2pm.  Was still tired.  Felt much better by 7pm on 5/1.  Feel normal on 5/2.
Gave Moderna Bivalent Booster for their 1st shot 50mcg/0.5ml dose. They should have received the regular monovalent dose as their first shot.
Radiating pain, into the back; Radiating pain, up and down in his arm; Radiating pain, shoulder; This spontaneous case was received on 04-Oct-2023 from other healthcare professional (pharmacist) and concerned an 86-year-old, male patient.   The patient's medical history and concomitant medications were unknown.   On an unspecified date in 2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as '0.5', route of administration and anatomical location: not reported) for prevention of influenza disease, as reported. The batch number reported was 371626 and expiry date 30-Jun-2024.   On an unspecified date in 2023, after receiving Fluad Quadrivalent vaccine, the patient experienced radiating pain, up and down in his arm and into the back and shoulder.  At the time of initial reporting, the outcome of the events 'Pain in arm', 'Back pain', and 'Shoulder pain' was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with the case 202304562 (the same reporter).  Company comment: On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, an 86-year-old patient experienced pain in his arm, back and shoulder. Due to unclear temporal relationship, causal role of the suspect vaccine is unassessable for the events of pain in arm, back pain and arthralgia.; Sender's Comments: On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, an 86-year-old patient experienced pain in his arm, back and shoulder. Due to unclear temporal relationship, causal role of the suspect vaccine is unassessable for the events of pain in arm, back pain and arthralgia.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that on an unknown date, the patient experienced an injection site reaction to the vaccine ZOSTAVAX. The patient experienced significant redness, bruising and swelling at the injection site. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
One day post vax pt developed redness and swelling in right thigh. Pt was treated with Keflex for 7 days. Pt returned to clinic 3 days later with redness and persistent swelling. Pt was instructed to continue Keflex and apply warm compresses.
Pt was given anthrax, typhoid, flu and yellow fever on 11/14/2022. Approx. 2 minutes after shots were given pt was noted to be leaning over to her side in the waiting chair, with fist clenched. Pt was not not responsive to verbal or painful stimuli. Pt eyes were dilated, skin were diaphoretic and flushed. Pt was able to answer questions approx. 1 minute after contact. At this time she was A/oX4. Pt then complained of confusion, lightheadedness, and nausea. An ice pack was placed in the back of the pt head and she was placed supine with knees propped up. Ambulance response team was notified and care was transferred with out issues
Leg weakness, extreme fatigue, protein and in urine - 3 months Dialysis 3x week since 2/7/22 through present 1/15/23
PT HAD SWELLING AND REDNESS IN RIGHT ARM ABOUT THE SIZE OF A BASEBALL. ADVISED TO USE BENADRYL AND A COLD PACK ON SWOLLEN AREA. THE NEXT DAY, I SPOKE TO THE PT DAUGHTER. SHE INFORMED US THAT THE PT HAD A PREVIOUS PNEUMONIA SHOT IN MARCH (7 MONTHS AGO) AND THE PT FAILED TO INFORM OUR OFFICE OF THIS FACT. THE PT WAS ACCOMPANIED BY HER SON AT THE TIME OF THE VACCINATION.
This spontaneous report as received from a other refers to a patient of unknown age. On 19-JUL-2017 the patient was vaccinated with M-M-R II lot # L023385, subcutaneous for prophylaxis. On 19-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Mom called the afternoon of 07/18/2007 to report fever and upper right arm swelling.  Immunizations received 07/17/2007 at walk-in immunization clinic from 4:00 - 6:30 PM.  Mom did not have a thermometer to check his temperature but stated he felt very warm.  Treatment with Tylenol, push fluids and cool cloth to right arm.  PHN called mom back 07/19/2007 in AM for follow-up. No longer had fever but upper right arm remains swollen and warm to touch.  Mom continuing Tylenol for discomfort.