chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness/Lightheadedness; Weakness; Headache; Chest discomfort; Fever; Injection site pain; Feeling as though head is altered/drugged; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old 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 03Oct2021(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Oct2021 at 18:00, the patient experienced chest discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain and feeling as though head is altered/drugged. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest discomfort, dizziness/lightheadedness, weakness/tiredness, headache, fever, injection site pain, feeling as though head is altered/drugged was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
After receiving the Flu Vaccination, felt nauseous and an odd sensorium occured a few minutes after administration.  Pt. did not fall or lose consciousness.  Pt. also had same symptoms last after receiving the Flu Vaccine, it was attributed to a hot crowded room where vaccine was administered.  Pt also had a Tetanus/ Diphtheria vaccine about month prior without any reaction or symptoms.
This spontaneous case reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus) and chills in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included plasmapheresis (plasma infusion done) on Feb 24, 2021. Concurrent medical conditions included cancer (takes unspecified cancer meds). On Feb 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 24, 2021, patient had COVID-19 (COVID-19 virus) and chills. At the time of the report, COVID-19 (COVID-19 virus) and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications included unspecified cancer medication. Treatment for COVID-19 event included a plasma infusion.
Pt reported swollen lymph nodes to neck and burning behind ear drums. 3 days after ADACEL/MMR II injection. Pt has been to ER (on 2/22/09 and wk another ER on 6/1/09). Pt also has pain at the base of his skull.
Information has been received from a physician concerning a 15 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot not reported). On 22-mAY-2008, 48 hours post vaccination the patient went to the E.R. experiencing shingles rash on her neck. The patient was given unspecified pain medication and discharged from the E.R. The patient's outcome was not reported. Additional information has been requested.
Fever, redness at site on 8/19/15. 8/20/15 Fever increasing to 103, vomiting, nasal drainage, refusing to crawl or wt bearing, swelling left knee, elevated inflamm markers. To ER admit for IV Abx.
101 degree fever, headache. The unusual side effect is that my body did not sweat even though I was running a high temperature for me. I have never experienced a high temp where my body did not sweat. I am concerned that the 2nd dose was excessive and not needed.
both of them got positive after getting the 1stdose; both of them got positive after getting the 1stdose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients (husband and herself). This is a 2nd of 2 reports. An unspecified aged male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 15Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient asked that he can take the COVID-19 vaccine 2nd dose and is scheduled for 15Mar2021, and both of them got positive after getting the 1st dose scheduled last 15Feb2021. Outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268439 Differente patient, same drug and AE
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
2 weeks post booster started itching.  Hives, wheals, rash, dermagraphia.  Itching was and is awful.  Skin crawling.  Does go away with antihistamines, but comes RIGHT back if I skip them for the say.    my sister (41) and my son (19) both have the same symptoms and both 2 weeks post Moderna booster.
Fluttering heartbeat, pounding heartbeat, radiating pain from center of chest to left armpit
about 24 hours after injection, extreme lethargy, headache, chills, but no fever. I just slept the rest of the day and bundled up. I was fine by this am.
"Today for left arm pain, swelling, increased warmth, decreased ROM in left arm, and body aches since she had her pneumonia shot on 11/8/18. She notes that the redness of her left arm has been getting worse over time. Pain is plus 8-9/10 with rest plus 10/10 with movement. She had a low grade fever, nausea, and diarrhea a few days ago but this has resolved. Denies any chills, SOB, chest pain, vomiting, numbness, or tingling. She is taking MOTRIN 800 mg every 6 hours with slight improvement in pain".
headaches, dizziness and L arm twitching s/p COVID administration on 1/3/21 @ 1900.  Patient reports that after receiving her first COVID vaccine yesterday she started complaining of being "tired and achy." She confirms that she subsequently developed a bitemporal pounding headache 5/10 pain that lasted an hour with associated blurry vision. No associated photophobia, phonophobia, nausea or vomiting. MOC also noted several episodes of patient's left arm "twitching" in the arm that was injected with some associated swelling. Each episode involved entire UE and resolved within a couple of minutes. Patient had another 30 minute long headache this morning, characterized as pounding bitemporal. She continued to have intermittent dizziness, did not develop any syncope, URI symptoms, diarrhea or vomiting. Patient was given a one time Advil dose that improved the headache. The dizziness has made it more difficult for her to ambulate, but she has not fallen and has not had any pre-syncope.
A couple of minutes after receiving the first dose of Pfizer, patient felt faint, was clammy and pale. BP 58/38 HR 62, SAO2 98%,. Appeared to be having a vaso vagal episode. Never lost consciousness. Patient taken by wheelchair  to cot, laid supine, legs up.  BP then 110/66  HR 83. Patient feeling better. Patient able to sit up and drink water, ?feeling normal?. BP 107/67 HR 82 and discharged in stable condition with mom. Patient and mom stated that pt was extremely nervous and anxious about vaccine and stated that he is scared of needles.
Booster dose administered to child; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication taken. No treatment medication received.
Information has been received from a registered nurse (RN) concerning a male who was vaccinated with varicella virus vaccine live (Oka/Merck). On 24-May-2007, after the booster dose of varicella virus vaccine live (Oka/Merck), the patient experienced a local injection site reaction described as a large hive at the site of injection (date of first vaccination not reported). The patient was not seen in the physician's office and has been treated symtomatically by his mother at home (treatment therapy not reported). As of 25-May-2007, the patient was reported to have been recovering. The primary reporter requested a lot check be completed on lot # 654754/1333F. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. This is one of several reports received from the same source. Additional information has been requested.
Nausea, then fainting at around 4:00 AM following shot. Hydrated, supplied anti-nausea medication in ER.  Rested the next day, took it easy for a few days. No further issues. Diagnosis on ER visit summary was pre-syncope.
pt recv vax 3JUL95 & on 2MAR97 pt devel a varicella-like rash;It was also reported that pt sibling (WAES #97030585) had a similar rxn to varicella vax;
On 5/29/08, child revieved his 2 months vaccines: Hep B #2, Prevnar #1 and Rotateq #1. Next day Mom noticed slight bright red blood in stool.  Doctor not notified. On 6/12/08 child recieved vaccine Hib #1, no adverse reaction.  On 7/29/08 child recieved vaccines Pediarix #2, Hib #2, Prevnar #2, and Rotateq #2.  Mom on 7/30/08 notifies doctor that childs bm had a small clump of bright red blood after 24 hours of getting vaccines.  Doctor reporting incident to be Hematochezia due to Rotateq vaccine.  Future Rotateq immunization will not be given for future dosing. No treatment was given, next bm was normal.
Developed a mild headache about five hours after injection. That was not uncomfortable. I then developed intense chills that woke me up from sleep  14 hours after injection.   I had pain in injection site, fatigue, non-stop chills, body aches, joint pain, muscle pain, cough, and difficulty eating (but not nauseated) and slight fever - just less than 100 degrees the entire first night, next day and night from the second injection. The joint and muscle pain was so intense in my elbows and wrists, that it caused me to break down crying as I was trying to drive home from work at 9 AM the following day after injection. The joint/muscle pain persisted and I would get some shooting pains in my toes, feet, hands, and wrists on and off for roughly 12 hours the day after injection. Lymph nodes have also been swollen in my throat since 14 hours after injection.   Naproxen did not ease this pain or discomfort but it did keep a fever at bay (but still with chills nonetheless) so at the recommendation of my sister who's a doctor, she said I should take the max dose for short periods of time at 2 pills, 3x a day. After taking two at once, that made the chills go away but not the body aches.
Patient received Pfizer Covid-19 vaccine at an off-site clinic. Patient complained of being light-headed/dizzy. She appeared frightened and after a couple of minutes felt as if her lips were beginning to swell. Patient was offered and received benadryl liquid orally and felt better after 15 more minutes and left after declining any additional treatment.
Mother states noticing rash on child face then spreading to torso and arms, states rash started about 2days ago, states mild fever. Mother brought child to health dept today, 10-27-06. Rash is pink, is starting to fade from face but still highly visible in torso. No treatment given, advised to give acetaminophen for fever.
8 HOURS AFTER THE INJECTION I NOTICED REDNESS, TENDERNESS, HEAT AND KNOTS AT THE INJECTION SITE. THE FOLLOWING MORNING THE IRRITATION HAD INCREASED AND GROWN IN SIZE AND  INCREASED THROUGHOUT THE DAY AND INTO THE NEXT DAY. THE FINAL SIZE WAS THAT OF A LARGE SOFTBALL. BY THE FIFTH DAY (7/13/21) THE REDNESS ETC IS DISSIPATING AND OTHER SYMPTOMS ARE FADING.  TREATMENT WAS BENADRYL AT BEDTIME AND IBUPROFEN DURING THE DAY.  NO DR OFFICE VISIT NEEDED, BUT I DID NOTIFY THEM OF THE REACTION SO IT COULD BE NOTED IN MY MEDICAL RECORDS.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with VARIVAX (dosing details unknown) from lot # L016123 that had expired on 06-MAY-2017 for prophylaxis. The reporter further stated that the vaccine was exposed to a temperature excursion of 5.9 degree Fahrenheit for 1.5 hours prior to administration. No adverse symptoms were reported. There was no previous temperature excursion. Data logger was involved. Product quality complaint was not involved.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
dizzy; feeling very fatigued; skin feels like things are crawling on it, both legs an arms; with the enduration around the injection site hot; bruising in the middle part; lymph nodes near the left ear are swollen; with the enduration around the injection site red; her arm where she received the injections is swollen; Left lymph node under armpit is "bubbled out"; induration around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot) and VACCINATION SITE BRUISING (bruising in the middle part) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site). On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy), FATIGUE (feeling very fatigued), FORMICATION (skin feels like things are crawling on it, both legs an arms), VACCINATION SITE WARMTH (with the enduration around the injection site hot), VACCINATION SITE BRUISING (bruising in the middle part), LYMPHADENOPATHY (lymph nodes near the left ear are swollen), VACCINATION SITE ERYTHEMA (with the enduration around the injection site red), VACCINATION SITE SWELLING (her arm where she received the injections is swollen), LYMPHADENOPATHY (Left lymph node under armpit is "bubbled out") and INJECTION SITE INDURATION (induration around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller was able to sleep last night by intermittantly applying cold compresses to her arm.
Urticarial lesions surrounding shot sites, self resolved after one hour. New urticarial self resolving lesions erupting over extremities. No lip swelling or shortness of breath.
Initial report received on 27 July 2009 from another manufacturer whose initial reporter was a consumer. A unidentified male patient received INFLUENZA VACCINE (manufacturer and lot number unknown) on an unspecified date. Post vaccination the patient developed paralysis for a few months and had "Geon Berry disease". The patient stated that he did not want to provide further information because the facility has already documented this information. Recovery status was not reported. List of Documents held by Sender: none.
Fever, chills, headache joint and muscle pain, rash lasting five days. Injection arm stll swollen and hot three weeks later. Shoulder joint frozen and painful still. Xray says no arthritus. Doctor prescribed physical therapy
2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 14th September 2022 with lot number 299J9 and expiry date 01st July 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Apr-2023 The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Pt experienced a syncopal episode - regained consciousness approx 30 seconds later. Pt was oriented to person, place, date. Pt given juice, and was observed further. Pt was then checked by Dr. and allowed to leave.
Shot given into left shoulder joint. Immediately felt popping and crunching sensation with radiating pain following. Within 2-3 hours of injection could not lift left arm.
I broke out in hives on December 16th, 2021 1 week and 1 day after receiving the Moderna booster shot. I only had fatigue, body aches on the first day just like my second shot of Moderna. I was feeling great until December 16th, 2021. The hives started on my hairline on the back of my neck and now have progressed to all over my body. I have no allergies to food or medication. Every time my skin touches something it leaves a red mark or streak and extremely itchy bumps pop up everywhere.
felt lousy, laying on couch for 8 hours; cold; This is a spontaneous report from a contactable consumer or other non-health care professional (Reporter's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced felt lousy, laying on couch for 8 hours and cold. Further caller inquired Can her daughter get 2nd dose OF Pfizer Covid 19 vaccine outside of 3 week mark. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Vaccinations at 10AM on 8-27-08 with onset of urticaria at 530PM on 8-27-08.  ER visit at 6PM on 8-27-08 and given steroid injection and oral Benadryl.  Office visit in doctor's office on 8-28-08 with continuing urticaria and patient instructed to continue on Benadryl.
Patient got red splotches over his face & legs. No rash on trunk. He cried initially then consoled easily. He was given BENADRYL 1mg/kg 25min after vaccines were given & observed.
No additional AE information provided.; HCP states that ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report has been received from a pharmacist referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 26-SEP-2022, the patient administered with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot# W002561, expiration date 07-OCT-2023, dose, frequency, anatomical location and strength were unknown) orally for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 9.13 degree Celsius (C) for 1 hour and at minimum minus 8.45 degree Celsius (C) for 37 hours and 15 minutes (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was provided (no adverse event).
Per patient: few minutes after receiving flu injection of 0.5 cc sneezing and runny nose for 15-20 minutes, arrived at home, laid down, eyes became puffy, hives all over body, throat became sore and appeared swollen., Went to hospital emergency room.
patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.