chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and slept all day. Then yesterday when she awoke she had a sense of discomfort in the left eye, and a friend who helps them at home noticed that her left eye was slightly bloodshot. Yesterday she went to see her eye doctor who dx her with an incidental small burst blood vessel but did not advise stopping eliquis and said it should resolve within weeks. She has no loss of vision. However, in the evening when at home she said she had difficulty forming words - husband did not particularly notice a problem - she ignored it basically and went to sleep . Then this morning went to the hairdresser, noticed the word finding/ speech 'garbled' slightly problem again and walked into her pcp office - she was eval'd there at approx 1140 am and sent to ER by ambulance. Code green not called given the initial deficit was last night, CT head suggested possible subacute infract. She had no chest pain or pressure, trop noted as slightly elevated at 129 , Platlets 84 Diagnosed  with Bilateral punctate infarcts throughout the brain, in cerebellum, occiput, left temporal and parietal lobes
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant (She had bone marrow cancer) in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (sore arm). In February 2021, MYALGIA (sore arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   ice, tea and fluids were treatment medications. No concomitant medication was reported. Reporter reported that she had bone marrow cancer.   This case was linked to MOD-2021-320894, MOD-2021-320895 (Patient Link).
My brother had a Moderna 1st vaccination early in March and has not had one since; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No allergies, current illness, lab data and medical history was provide by patient. No concomitant and treatment medication was provide by patient.  Patient brother reported that patient had only one dose of Moderna in early march and had not taken one since.; Sender's Comments: This report refers to a case of Product dose omission for mRNA-1273 with no reported adverse events.
6 hours after injection I started feeling sick. Symptoms included severe headache, aches, chills, nausea and abdominal discomfort. Treated headache with OTC meds.
Pain at the injection site for 2 days after the shot, the pain went away.  Per patient, she got pain back on the day she came to pharmacy on 11/4/2014.
Patient has been diagnosed w/ Polymyalgia Rheumatica.; This is spontaneous report from a contactable other-HCP.  A 61-year-old female patient received the second dose of BNT162B2 (Lot Number: EW0161) at single dose for COVID-19 immunisation on 15Apr2021 at 02:30 PM. Relevant history included HTN, Hypothyroidism, HLD, Hyperglycemia, Vit D Deficiency, Radiculopathy Lumbar Region. Relevant concomitant drug included ascorbic acid, retinol, tocopherol (OCUVITE), Enalapril 5mg, Vitamin D3 50000 IU, Atorvastatin 10mg, Bisoprolol/HCTZ 10/6.25mg, levothyroxine sodium (SYNTHROID) 200mcg. Past drug included NKDA (as reported). The patient previously received the first dose of BNT162B2 (Lot Number:EP7534) at single dose for COVID-19 immunisation on 18Mar2021 at 02:30 PM, without side effects after 1st vaccine. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Approx 7-8 hours after 2nd vaccine (as reported),  the patient started to experience intense leg and arm cramps and pain in her joints with a 10/10 pain level.  She needed assistance getting into an upright position.  The pain continued to worsen.  She was put on Meloxicam without relief.  Then Prednisone 10mg was started which had significantly help with her symptoms.  She still had some pain in her knees.  Patient had been diagnosed with polymyalgia rheumatica. The patient visited the doctor or other healthcare professional office/clinic due  to the events. The outcome of events was  resolving.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between 'polymyalgia rheumatica' with symptoms of 'leg and arm cramps' and 'pain in joints' and suspect product cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Black and blue spot where vaccine was given.  After several days a red baseball size red spot appeared and grew in size to almost double.  The spot was hot to the touch and was  somewhat itchy.
Moderate to severe unilateral headache  unresponsive to Tylenol or  Advil on day 3, 4 and 5 (today). The headache gets better after several hours but returns.
9 days after vaccination, the patient was found deceased in his home, sitting on his couch. Determined to be due to pulmonary embolism.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2015, as reported since 20-APR-2015, the patient was vaccinated with improperly stored ROTATEQ, oral. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
after 6 hrs injection of 2nd dose, left arm was swollen  felt tender.  That night, I feel chilled; not feeling very good.  Next day same prblem especially chilled; went to bed under blanket to warm up  Its now 12:36 next day, no improvement
Pain in hips; pain in kidney area; Pain in hips; pain in upper kidney area; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (on and off since the age of 18 years).   In November 2018, the patient received the 1st dose of Shingrix. In February 2019, the patient received the 2nd dose of Shingrix. In September 2019, not applicable after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced pain in hip and flank pain. On an unknown date, the patient experienced pain in hip and flank pain. The patient was treated with gabapentin (Neurontin (Gabapentin)) and pregabalin (Lyrica). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in hip and flank pain were recovered/resolved and the outcome of the pain in hip and flank pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in hip and flank pain to be related to Shingrix. It was unknown if the reporter considered the pain in hip and flank pain to be related to Shingrix.  Additional details were provided as follows: The patient had shingles on and off since the age of 18 and had been on pain medications in the past such as Neurontin and Lyrica.  She states that the Neurontin did not help her and the Lyrica helped her but put her in a deep sleep. The patient states that she went to her pharmacy to asked about having another booster and she was told to call and that she could not get another dose. She states that she had terrible pain previously that went away when she had the 1st dose of Shingrix. Two and half months before the date of reporting, pain returned. She states that the pain was in her hips and upper kidney area. The patient asked if had any information regarding Marijuana for pain.
pt states that she got a terrible headache and she started throwing up next morning and did not stop for at least 12 hours. she had 100.1 fever and diarrhea.  Pt spoke w/ her PCP on 4/5/2021 and she was told to give it some time that she would feel better soon and to drink plenty of water.   Pt was not able to keep water down until early today 4/6/2021.  Pt says she is exhausted and very weak but all of her symptoms have subsided.
COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON 1-23-2021 DUE TO HYPONATREMIA
Extreme shoulder & underarm pain, swelling opposite of injection site on deltoid, disruption of daily activity and difficulty sleeping
vomiting, diarrhea, lightheaded 8/26/99 IV hydrated felt much better;returned to duty;
several days p/vax pt devel an inj site rxn characterized by redness & bruising which measured 3" by 4";
Extreme headache (worst I've ever experienced), extreme body-ache, nausea, high temperature (100.6 deg), skin felt like on-fire but was unable to sweat. This lasted about 10 hours (by evening I was feeling alot better after taking Ibuprofen). This was followed by 2 days of low energy and upset digestive system. I have had flu before but the pain I was in was so much worse than that, horrendous.
Myalgia, Arthralgia, sore throat, runny nose, swollen glands, chills, Narrative:  A few hours after receiving the vaccine, the patient reported the following symptoms: left upper arm soreness (injection site), runny nose, sore throat, and swollen glands. The following day, her symptoms persisted and she  also reported back pain and chills.  Other Relevant History:
Pt was vaccinated on 05/06/97 and on 01/24/05 came down with a rash diagnosed as chicken pox, reason for reporting is because several other pt's have chicken pox that were vaccinated.
Varicella vaccine was given 6days prior to patients first birthday. No reaction. No problems noted.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age, who was the reporter's husband. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 09-APR-2013, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported). On 15-JUN-2017, the patient received another dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours and on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
About 24 hours after the injection, I developed a headache, fever, chills, and general muscle aches, in addition to a very sore arm around the injection site. I was sick in bed for two days. No treatment was given or received.
pt says she took a pregnancy test before taking the covid vax that read positive.  she had a sore left arm for about 2 days.  On 4/5/2021 she had some vaginal spotting  but pregnancy test was still showing positive.   On 4/7/2021 she went to her PCP.  They gave her a pregnancy test that was positive.  They expect she was about 4 weeks along.  She was referred to her OB/GYN.  On 4/10/2021 she had vaginal bleeding.  She contacted her PCP and was instructed to go to the ER.  She went to Medical ER.  they did a vaginal US, US on her stomach along w/ urine test.  She was told that all results were negative and there was no longer a fetus.  She was about 5 weeks along at this point.  She has never been pregnant before but hormone levels are great before this incident.
Left arm pain, redness, swelling about 2-3 inches below injection sites. Area about 3 inches in diameter that is red, tender, painful. Discomfort started 11/7. By the evening of 11/7, there was severe pain in left arm requiring prescription medication for relief. Redness and tenderness continues 11/9.
fall (frequently), dyspnea, fever, COVID+. with mild hypoxia. treated with dexamethazone , zinc,and 2 LO2. Hypoxia resolved after day 3. CPAP at night. titrate O2 to 1L.  PT refused placement. DC home
3 1/2 x 4 inches flat round red area. (no itching, no pain, not hot to the touch). Patient was instructed to cover the area to avoid exposure to other people and to apply Vaseline if it became bothersome. The patient did apply Vaseline but the irritation resolved it self by Saturday 12/23/2017.
Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date(s) was vaccinated with the FLU vaccine (manufacturer unspecified) and PNEUMOVAX23 and had an adverse reaction. The "date of loss" was reported as 11OCT2013. The Lot # reported for the PNEUMOVAX23 was reported to be J004080 with an expiration date of 22AUG2014. It was reported that it was unclear which vaccine she had the reaction to. Treatment and outcome of the adverse experience was unknown. Additional information has been requested.
Administered FLUVIRIN vaccine to patient and patient became weak and shaky within 10 min after receiving shot. Patient was transported to the emergency room.
4TH DOSE (2ND BOOSTER) GIVEN BEFORE ELIGIBLE. PT REPORTS NO ADVERSE EFFECTS
Sudden profound hearing loss in left ear on November 6, 2004 after receiving flu vaccine on October 30, 2004.Tested twice by audiololgist, have seen speialist twice, MRI has ruled out acoustic neuroma.  Will see neurootologist on December 28, 2004.  Trying to get appointments with a neurologist and virologist.
Initial report received from a patient on 17 August 2007. A 46 year old, female (with a history of allergies to trees, grass, shellfish, mycins, sulfa, PCN) felt lethargic, mildly achy and slightly nauseated, the day after she received her second dose of IMOVAX (lot number A0208-2, route of administration not reported) in the right deltoid on 11 August 2007. The symptoms subsided after a day except for the aches. She did not have any illness at the time of vaccinations and was not any medications. She had not recovered. Follow-up information was received from the health professional on 24 September 2007, which noted that IMOVAX dose one had been given on 08 August 2007, dose three on 15 August 2007, dose four on 20 August 2007, and dose five on 05 September 2007. Route of administration was confirmed as intramuscular. Outcome was unknown. The patient also complained of sweating chills, the night after she received her first dose of IMOVAX and IMOGAN - detailed in case 2007-02826. She also experienced adverse events after receiving the third dose of IMOVAX - detailed in case 2007-02828.
Pt went to local ER dead on arrival. Follow-up with mom states she brought baby to ER because he stopped breathing. Autopsy revealed SIDS.
Red raised welts & hives, localized within 4 inch radius of injection site. Very painful to touch but not itchy. Welts expanded and merged next 24 hours, but did not extend beyond 4 inches of injection site. Lymph nodes swollen & painful in upper arm, armpit & neck on same side as injection site. No difficulty breathing, so clinic recommended oral BENADRYL, and if not resolved within 4 days of initial injection, then return for further treatment.
headache, dizziness, confusion, forgetfullness and increasing paranoia. The parahnoia increased over the following several days to almost psychotic ideations (that i was the chosen savior), fears of dying, visions of the world ending, and extreme suicidal ideation.  I myself am a psychotherapist so I forced myself to do meditations, talk to colleagues and attempt to calm myself.  The paranoia has subsided today (8-26-21). although dull headache continues, with some memory problems.
Raised red area very pruritic/raised similar to urticarial wheal. Better after ice applied.
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/15/21). Patient was admitted to the hospital on 7/25/21 with about 1 week of fever and cough. On admission patient was afebrile but hypoxic initially placed on BiPAP then escalated to HFNC. She was initiated on corticosteroids and anticoagulation tocilizumab and remdesivir. She is still requiring HFNC and will continue on remdesivir (day #1 of 5).
My arm was sore within 8 hours of receiving the vaccine.  About 21 hours after receiving the vaccine I had chills, fever, headache, muscle ache, chest tightness, light-headedness, and fatigue.  After my fever broke Friday morning, I continue to have a horrible headache, light-headness and fatigue.
Developed a severe sore throat about 24 hours after the vaccine.  The following day coughed up blood from the throat. On January 11 developed severe laryngitis.  The condition continues without relief.  Sore throat  and no voice .
ERYTHEMATOUS PRURITIC MACULAR PAPULAR RASH ON LEFT FOREARM, RIGHT FOREARM AND DORSAL SURFACE OF LEFT FOOT.  RASH BEGAN TUESDAY EVEINING AFTER SHOT GIVEN EARLIER THAT DAY (10/12) SITE OF INJECTION COMPLETELY UNAFFECTED.  FREE OF RASH, SWELLING, ERYTHEMA OR INCREASED TEMPERATURE.  LEFT FOREAREM MOST PRURITIC-TREATED WITH TRAIMCINOLONE CREAM 0.1% BID SPARINGLY
Patient received her 1st dose of Shingrix on 10/15/19 at a Pharmacy. Proper technique used to administer IM to left arm. Patient returned to pharmacy on 10/17/19 with a rash on injection site, painful to touch, but not itching. Patient states that rash started on 10/16/19 (day after shot). Followed up with patient on 10/18/19 who stated that it was warm and painful to touch. The rash had been 3 separate spots around the injection site but now fused into one red area. No blisters. Patient using ice and ibuprofen. Patient will contact MD 10/21/19 if not better.
huge red mark a injection site; arm is hot and itchy; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST, ATORVASTATIN, VENLAFAXINE, SPIRONOLACTONE, THIOCTIC ACID, UBIDECARENONE (COENZYME Q10 + ALIPOIC ACID) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.