chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took Phizer Covid vaccine Two hours after had bad dizzy spell , then another before bed. Woke up with severe lightheadedness then about two hours felt like i was gonna pass out blood pressure extremely high . Went to ER this lasted for about 2 hours, had to get meds fir dizziness. Still having dizzy spells and cant find cause. Have been to allergist and ENT doctor many test
Rash, fatigue, joint pain, low grade fever, chills, nausea, muscle pain
A rash developed near site of injection a week after getting first dose of moderna covid 19 vaccine. It?s itchy, red, hot to touch, and raised. Size is about 2 inches wide and not uniformed.
From the evening of the day I received the vaccine I had migraine, muscle pain, joint pain, hot flashes, insomnia, dehydration, fatigue, and my eye sight was getting bad. All resolved by 4pm Wednesday March 31st but my eyesight is getting progressively worse. I cant read anything on the TV. Normally with my contacts I have 20/10 vision but now with my contacts in I still cannot see anything clearly.
no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 21-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002419: US-009507513-1904USA002418:
9 days post-injection, I got a big itch red hive all around the injection site. The spot of the injection is also a hard lump.
Reported Symptoms: 10033371:PAIN; Narrative:  Other Relevant HX:  Other:
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 14-APR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reporter as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
After injecting needle in the patient's arm, upon injection of vaccine, the vaccine started to leak from the hub.
She had a soft patter sound in her ears that Happened when she burped and bent over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6200) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (She was considered cancer free 5 years past her diagnosis) in 2001, Shoulder replacement in 2020 and Cardiac ablation (She had Cardiac ablation about 3 years ago) in 2018. Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 Vaccine (Pfizer Lot Number: EL3427 She reported she got her first Covid vaccine in her left arm) on 05-Feb-2021. Concurrent medical conditions included AFib (She was diagnosed with AFib in either 2015 or 2016) and Osteoporosis in 2020. Concomitant products included APIXABAN (ELIQUIS) for AFib, DENOSUMAB (PROLIA) from July 2020 to an unknown date for Osteoporosis.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over). At the time of the report, TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Acoustic stimulation tests: normal (normal) Normal.         She has been on Eliquis 5mg tablet for about 3 years. On 01-Mar-2021, her second Covid vaccine was between 1:00 to 1:30PM On 15-Mar-2021, her ear doctor cleaned and waxed out both  ears, and checked her ears, nose, and throat. On 07-Apr-2021, her ear doctor dug out a skin flap in her right ear but that did not take care of the soft patter sound in her ears.   This case was linked to INC.-MOD-2021-089491, MOD-2021-185552 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No significant information received; Sender's Comments:  INC.-MOD-2021-185552:Dose 1 INC.-MOD-2021-089491:Same reporter
Pt given flu and MCV4 same arm. 6 hrs post vacc. - red, itchy, swollen at injection site right arm. Pt notes fever last night, now with nasal discharge and sore throat. Pt re evalauted 3/1/12 by MD - cold compress applied right arm, administered 400mg ibuprofen, rx given for hydroxyzine and Keflex, DC'd to home, advised to watch for increased signs symptoms of infection/fever.
On 10/7/02, numbness on left side of body, face and torso.  Optic Neuritis-left eye.  Dizziness.  MRI of brain on 10/11/02 indicated demyelinating disease with one lesion and several scattered white matter foci within the bilateral frontal/parietal lobes. Information from 60 day follow-up report states: Multiple areas of white tissue damage on top of brain-lesions, balance problem, ataxia, numbness on left side of body, neuropathy, optic neuritis - left eye, persistent headaches, fatigue, diminished cognitive function - autoimmune disease. 12/31/09 Continued white tissue damage/lesions on top of brain. Balance problems-Ataxia, numbness-left side of entire back. Neuropathy, optic nueritis-left eye, persistent headache, fatigue, diminshed cognitive functions-auto-immune disease demyelination.
expired dose of Ipol was inadvertently administered to a patient/ no adverse event; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 3 months old male patient who received an expired 0.5 ml dose of suspect IPV (VERO) [IPOL] lot number N1A461M via (Expiry date 09-Feb-2019) intramuscular route in the left thigh, On 09-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to expired vaccine used.  The patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Vaccine injected directly into shoulder joint. Extreme shoulder pain, lack of mobility, unable to lift arm 3 weeks later.
A non-serious spontaneous report of 22-month-old male child receiving H1N1 was received from a registered nurse/health professional. The patient had no medical history and no concomitant medication was taken by the patient. On 12-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The child had not developed signs/symptoms of the flu and child remained well. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 12-Nov-2009 and incorporated into the narrative: date of vaccination changed, medical history and concomitant medications. Additional information was received on 18-NOV-2009 and incorporated into the narrative: sex of child changed to male, medical history and concomitant medications verified as none.
On 08/16/2019 patient reported to the pharmacy with a prescription for antibiotic. Patient stated that they had a skiin infection following Shingrix vaccination. Patient did have a red patch of skin approximately 4 and 1/2 inches on right deltoid.
My 8-year tested positive for COVID-19 on December 31st. I was tested on January 06 for COVID-19 and it was positive also. I experienced tons of congestion, low energy and a headache. I did not have a lot of coughing. When we tested positive, we just monitored ourselves. We did not go see a doctor, I just managed it with Dayquil. I did make a complete recovery after about 8 to 10 days.
Vaccine admin 8/1/16 BEXSERO # 2 dose. Patient reports dizziness and "felt bad", chills on 8/2/16. Seen in office on 8/3/16 with local reaction of erythema, tenderness, generalized symptoms resolved by the time seen.
Received TIV approx 12:30. Reports pain down arm after injection. Approx 1 1/2 - 2 hrs. Post vaccination c/o chest and throat discomfort. States feels "jittery". C/o Tinnitis. 25 mg BENEDRYL IM given. Physician diagnosed: "Anxiety and (L) arm pain post injection" D/C home stable.
received their first shot of the Moderna Vaccine but never received their second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 (received their first shot of the Moderna Vaccine but never received their second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received their first shot of the Moderna Vaccine but never received their second shot) 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.   concomitants medication information was not provided.  Treatment information was not given.   This case was linked to MOD-2021-274272 (Patient Link).
Patient reports approximately 1 week after vaccine administration had hemorrhage vaginal, pelvic pain. Patient reports symptoms have not improve. Patient refers visiting her specialists (gynecologist, OBG) emergency room and did not find anything. Patient was under hospital observations received intravenous fluids.
Case number PHEH2014US022573, is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a 10 year old male patient. Pharmacist reproted that this patient received FLUCELVAX (batch number: 011021A) on 07 Nov 2014. No adverse event was reported. No further details provided.
Short of breath and had to go to the hospital for oxygen; pain in her arms; scared out of her wits; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced short of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits.  The patient's medical history included history of lung disease and previous pattern of experiencing shortness of breath and had COVID-19 in December. No concomitant medications were reported.  On 11 Mar 2021 date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 12 Mar 2021 date, the patient experienced shortness of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits. The patient was hospitalized. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcomes of events short of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits were  unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Heavy menstrual bleeding, off-cycle, lasting more than five days three weeks before cycle due.
The next day after my second dose shot of Moderna I felt so sleepy and Nausea that morning and later that night I felt dizziness and develop a fever of 105° I didn't take any medication for my fever it stayed for about 3 hours and finally went back to normal the third day I start to feeling much better
Large red, hard, itchy painful lump that has only gotten worse with time.  Covid arm maybe.
01/26/05, rash just started after noon today, patient has had varicella vaccine in the past.  Skin exam showed classic dew drop on a rose petal erythematous lesions with central vesicle on the back and anterior torso and neck area. Impression: Minor diagnosis of Varicella. Treatment: Isolation, Aveeno baths and Benadryl prn
Case number PHEH2015US025084, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 27-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. No adverse event was reported following this administration error.
Body aches; Diarrhea; Fever 102; Chills; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the arm left on 15Mar2021 at 13:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, COVID-19 and penicillin allergy. The patient received other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6200), via an unspecified route of administration in the left arm on 22Feb2021 at 13:30 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 02:00 the patient experienced Body aches. The patient did not receive any treatment for the event. On 16Mar2021 at 02:00, the patient experienced fever 102, chills, body aches and diarrhea for 24 hours. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 16Mar2021, the patient underwent lab test which included body temperature and the result was 102 (units unspecified). The clinical outcome of the events fever 102, chills, body aches and diarrhea were resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
About 11 hours after receiving the vaccine, I experienced a fever.  The fever started at 99.9 on 10/16, and increased to 100.4 most of the next day 10/17.  I also experienced really bad muscle aches.  On 10/16 it was mostly in my upper body.  On 10/17 it was mostly my lower body and left arm where shot was administered.  At 4am on 10/17, approx. 20 hrs after injection, I woke up shaking and shivering.  This lasted around 30 minutes.  36 hrs after injection, primarily left arm sore at point of injection.  Also fever still at 100.4.  Exhausted and not very hungry.
headache, fever, body chills, sore arm.  These symptoms lasted 24 hours
Patient presented to the ED with pelvic pain and fever on postop day #8, status post robotic assisted laparoscopic hysterectomy with bilateral salpingectomy, she was admitted with diagnosis of vaginal cuff cellulitis and was started on IV antibiotics. Sepsis evaluation was negative. DVT evaluation was negative. She received IV antibiotics >24 hours and remained afebrile. By hospital day #2 (POD#10), she was feeling much improved and meeting appropriate milestones for discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Hospitalization: 1/20/2023 - 1/22/2023 (2 days) Presentation to the ED: increasing abd pain and trouble urinating.  COVID + date: 1/20/23 Treatment: Did not require treatment.  Discharge to: home.   040C21A 7/23/2021 004F21A 8/21/2021
Tested positive Covid-19 infection,  Cough, bronchospasm, weakness, muscle pain, chest congestion, nasal congestion, Loss of appetite since vaccine given,
Patient became very stiff when son came home the next day she was unable to move. Son took her to then emergency room.
flu; covid; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient of an unknown age who experienced flu (influenza)  and Coronavirus disease (COVID -19), while she received vaccine INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant  medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and Coronavirus disease (COVID -19) (Unknown latency) following the administration of INFLUENZA VACCINE.  Reported Adverse Event Information: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign. The Race to 200M we are assuming the consumer is referring to the Sanofi flu vaccine. It was reported that mother got a flu shot and now has the flu and COVID. Please refer source document for complete information. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Not provided.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The outcome of events was reported as unknown.  There will be no information on the batch number for this case.
I had hives  (itchy and redness on neck, head, and chest and minor face swelling, onset about an hour after injection.  No trouble breathing.  I took a dose of Benadryl .  The symptoms started going away and only lasted 2 to 3 hours.
9/23/2015 patient reports hot flashes, weakness, dizzy and pain in injected arm.  Patient reports to continue to have pain at time of report on 10/5/2015.  Reports that she continues to have shooting pain down her arm to her wrist and up into her neck on the right side.  Pain is throbbing at rest and sharp with movement.
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 03-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-072040, MOD-2021-072040 (Patient Link).
The doctor was not able to administer the vaccine; There were two scratches in the vial; Case reference number US-BN-2022-000848 is a spontaneous case report initially received from a pharmacist via regulatory authority (reference number: USBAV22-0105) on 24-Mar-2022 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, there were two scratches on the RabAvert (Inactivated, Strain Flury LEP), batch number YRBA821A) vial and the doctor was not able to administer the vaccine to the patient (explicitly coded as 'product dose omission issue' and 'product container issue') for post exposure immunisation.  At the time of this report, it was unknown if another vaccine was administered to the patient nor if which dose this was supposed to be.  Additional information was received from Bavarian Nordic on 28-Mar-2022 included BN PQC reference and local BN case ID.; Reporter's Comments: The reporter stated that there were two scratches on the RabAvert vial (product container issue) and the doctor was not able to administer the vaccine to the patient (product dose omission issue). Product container issue and product dose omission issue are listed by convention. No information regarding medical history and concomitant medications was provided. No associated adverse events have been reported. Product container issue and product dose omission issue are not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: The reporter stated that there were two scratches on the RabAvert vial (product container issue) and the doctor was not able to administer the vaccine to the patient (product dose omission issue). Product container issue and product dose omission issue are listed by convention. No information regarding medical history and concomitant medications was provided. No associated adverse events have been reported. Product container issue and product dose omission issue are not related to the suspect product but to a human action. The case is considered as non-serious.