chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; aching body; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (aching body) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (aching body) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (aching body) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   No treatment information for the events was provided.   This case was linked to MOD-2021-221315, MOD-2021-221315 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: event outcome updated, patient reported she received second dose of the vaccine and experienced same adverse events. The events after both doses resolved in 1.5 to 2 days. she reported she is fine now. New case created for second dose.
felt nauseous after my second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (felt nauseous after my second dose of the vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (felt nauseous after my second dose of the vaccine). At the time of the report, NAUSEA (felt nauseous after my second dose of the vaccine) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Itching started around 8:30pm on 4/15, Hives started on inner thighs at 11:30pm on 4/15, took Loratidine at. midnight, hives were gone at 4am on 4/16.  Hives and swelling itching  returned on  4/16 worse and spreading on legs armpits and neck-other patches spread all overs, took Benadryl at 5:00pm no 4/16, worsening and went to a local urgent care for treatment around 7:00pm on 4/16, told it may be related to the vaccine as it did look like a medication allergy.  Given liquid oral steroids at urgent care and prescription called in for prednisone and hydroxyzine to be started the next day on 4/17.  Hives did not go away at all, able to sleep until about 5:30am 4/17 and woke to worse itching and hives spread even worse, all over legs, hips, arms stomach back and neck.  Pharmacy not open until 10am 4/17, to pick up new prescriptions, so was not able to take the hydroxyzine and  prednisone until 11:15am today, 4/17, which was 1 hour ago, still extremely red, itchy, swollen hives all over as of right now.  Will give the medicine more time to work before going to emergency room, since my breathing has been fine.
stomach bothering; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 23rd May 2019, unknown after receiving Shingrix, the patient experienced fever. On 24th May 2019, the patient experienced abdominal discomfort. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the abdominal discomfort was unknown.   It was unknown if the reporter considered the fever and abdominal discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever and abdominal discomfort. The reporter advised patient to refer to the healthcare provider for patient care. The reporter stated to patient that safety department would be interested in learning more about the experience with the product.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 17-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. On 30th March 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced pain and swelling at injection site. In 2018, the events were resolved. This is 1 of 2 cases, reported by the same reporter for the same patient.
This case was reported by a healthcare professional and described the occurrence of seizure in a 79-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included XYZAL, SYNTHROID, SIMVASTATIN, NYSTAN, ZYMAX, NEXIUM, IMDUR, GLUCOPHAGE, COZAAR, ALDACTONE, ACTOS, METAMUCIL, GLUCOSAMINE CHONDROITIN, ASPIRIN and CENTRUM SILVER. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced seizure. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL.
Arm injected sore at site, arm hard to move, knot and bruise where shot was given that has remained for 12 days.
EE attended a vaccine event at plant T1 and obtained his first dose of Pfizer COVID-19 vaccine at 3:35 pm. EE was instructed to wait for 30 minutes in the post vaccine observation area due to previous anaphylaxis response, to a medication as a child. EE was eating a snack when at 3:45 pm, he became light headed and stated "I feel like I am going to pass out." EE became pale and  Diaphoretic with an altered level of consciousness. EE was lower to a supine position on the floor and an ice pack was applied to head/ chest. EE states it is a little more difficult to breath, but I do not feel like my airway is closing up. No hives or reaction noted at injection site. At 3:45 pm airway was clear with no adventitious sounds noted. PERRLA with Oxygen level of 98% RA. Pulse 47. 3:50 pm EE unable to take Benadryl due to altered level of consciousness. BP: 80/60, Pulse: 69 and O2: 86% RA. EPI pen( Amneal 0.3 Mg, IM to the left thigh) administered per protocol and EMS was contacted. 3:52 pm BP: 95/70, pulse 82 and O2: 94% RA. Benadryl 25 mg administered orally per protocol. 3:54 pm BP: 100/85, O2:99% RA. Skin pink. EE states " I am feeling much better and do not need to go via EMS. EMS arrived at 4:00 pm and informed of care provided. EE was instructed that he needs continued monitoring due to EPI administration. EE was educated that he would not be able to obtain the second dose of Pfizer due to his reaction.
pt had a temp of 100.2 @ 4PM; 5PM had a temp of 103 & recvd 3/4 tsp APAP, cool compresses; temp was 103.8 2 9PM; pt was admitted to hosp @ 1230AM w/temp of 102.9; no swelling or redness @ inject site 7JUL93;
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction and product supply issue. On an unknown date, the outcome of the adverse reaction and product supply issue were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient was set to begin on insurance on 1st October 2018, knowing that the SHINGRIX vaccine was not covered under that insurance (like other vaccines), she planned to get both doses of the vaccine before 1st October 2018 so her current insurance would cover them. The patient was disappointed and quite angry to go back to the pharmacy in August 2018 (after clearing her schedule for a few days in anticipation of a reaction similar to the one she had after the first dose), only to find that there was no SHINGRIX vaccine available due to a nationwide shortage. The patient had checked back several times since then and got the same response. The patient was on a waiting list of people who have received the 1st dose and need the 2nd. The patient reported that, due to the company's mismanagement and spending more funds on advertising instead of producing enough of the vaccine to supply the demand, the patient would have to spend at least $150 to get 2nd dose and it seemed like she would not get it before the 6 month "window" which would be closed for on 30th October 2018. The patient stated she understood that the company believed it was not crucial to get the 2nd dose in the 2 to 6 month period recommended after the 1st dose, but the vaccine was not researched beyond that window. Again, the patient was very upset about handling of the rollout of this vaccine and would like for reimbursement for expense when the 2nd dose of SHINGRIX would become available to the patient. The patient would be happy to send receipts when she would finally have access to the shot.
Pt c/o formation of red welts & itching around inject site 6 hrs p/vax was given; the next morning red welts noticed on opposite arm & leg also itching;
Information has been received from a certified medical assistant concerning a 77 year old male who, on an unspecified date, was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 647655/0869N). Subsequently the was seen in the doctor's office for severe swelling at the injection site and redness at the site.  The pt's outcome was not reported. The reporter was concerned about the being tainted in some way. It was also reported that a female (WAES0410USA00293) and two unidentifiable pt's (WAES0410USA00499) developed severe swelling at the site and redness after vaccination with doses of pneumococcal 23v polysaccharide vaccine from the same lot. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 28 September 2010 the following vaccinations: an injection of ACAM2000 (lot number not reported), and Influenza Split Virus Vaccine (manufacturer and lot number not reported). The subject had no medical history. On 09 October 2010 the subject had an abnormal troponin I of 0.69, an abnormal electrocardiogram (ECG) and a normal echocardiogram. He was diagnosed with angina pectoris on 09 October 2010 and non-specific myocarditis on 10 October 2010 with the final diagnosis being carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Chest pain & abdominal discomfort began 04/11/21 in AM, continued into afternoon. 911 was called, per my Dad they performed an EKG & vitals check, said everything looked ok but advised he go to ER. He called me (his daughter) to drive him to ER (ER only, no med facility attached), he was admitted to room where vitals showed aggravated hypertension, took MD 30 min to get into room to evaluate, no intervention meds given at that time. CT scan performed, showing aortic dissection, after which he was given nitroglycerin via IV and "gastric cocktail" oral solution. They had to plan transport to another facility as this location was only an ER, barely got him into an ambulance and leaving parking lot for transport when he went into cardiac arrest. Ambulance paramedics performed CPR for 10+ min without result, he was brought back into the ER where staff continued CPR another 15 min, spouse had to make choice to stop CPR as his aortic dissection was now such a low chance of success and due to lack of oxygen, per MD, less then 2% chance of neurological recovery. He had an autopsy performed which showed aortic dissection, massive cardiac arrest as well as myocarditis and enlargement of the heart, fluid around the heart. All data provided here is either from my first-hand witnessing in the ER (I am a trained Medic) or the actual autopsy report and ER medical records my stepmom & I obtained after his death. He was pronounced dead at 9PM on April 11th, 2021; approx 3 hours after admittance.
5-7/2021 vertigo type symptoms resulted in 2 walk-in clinic visits and missed 2 days work Was referred to ENT for possible inner ear issues; after many tests and money that was ruled out.  An MRI was finally ordered and completed 6/10/2022-moderate white lesions on brain were noted.  9/16/2022 a lumbar puncture also showed results resembling MS. 11/16/2022 drove 5 hours to be diagnosed with MS and begin treatment.  This has been a very long road with many bumps along the way.  My life has forever changed from taking a vaccine that was safe?  I had always been a healthy individual but that has been taken away.
received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the bivalent Moderna Covid-19 vaccine for her first primary series dose instead of the monovalent vaccine).    No concomitant medications were reported. No treatment medications were reported.
That night I got a red rash on the back of my neck and a headache. The next morning my husband found me with my face all contorted and not able to speak real words, only gibberish. My back had a terrible pain all through it. He called 911 and they took me to the hospital where I still was not speaking words but I thought I was. I could hear myself saying actual words but everyone around me said I was not. I was in the hospital for 5 days.
Patient received a booster shot. Patient was fine, followed up with his mother today 11/18/2021, and she stated he is doing just fine. No complaints of any kind.
Information has been received from a 67 year old female who on 30-Aug-2007 was vaccinated with Zostavax.  Concomitant therapy included a dose of Pneumovax 23 (manufacturer unknown) and simvastatin (manufacturer unknown).  The patient reported that on approximately 01-Sep-2007 two days after she received the Zostavax she experienced pain in her groin after taking a walk.  She reported that her left side ached before the right side.  She took an aspirin and the groin pain disapated on the one side.  The patient also reported that she experienced an upset stomach.  She started feeling better but did not want to take her walk until she talked to her physician.  Additional information has been requested.
Headache Sunday night. Headache and lowgrade fever Monday morning.  Vomiting Monday afternoon.
2 weeks after the first dose the injection site became very warm to the touch and  dry itchy.  It lasted several days.
cellulitis at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed cellulitis at the injection site.  As a measure, this patient visited the emergency room where antibiotics were prescribed.  The outcome of this event was unknown. The reporter consented to follow up.
Extreme pain in shoulder that has lasted 3 weeks. Inability to move shoulder or function properly. Inability to sleep because of deep throbbing sensation.
2NOV95 redness (quarter size) @ inj site; states it started on 30OCT95-advised DPH & heat;4NOV95 went to ER erythematous area w/underlying tender nodule rt deltoid;
April 13 (I had been traveling before it and came back) and I was preparing for work and my foot hurt. I hobbled around that day and noticed my foot was swollen. The next morning, I went to Piedmont Hospital ER( on the 14th) - they gave me a starter dose of blood thinners and I was able to schedule appt with Dr. Shamm -my  hematologist -  Zeralto - was what she prescribed. Everything is "back to normal." But based on my health history - the doctor care will be ongoing and I'll continue to see this doctor for treatment.
No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 2-year-old female patient. On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
1 Days post vaccine: pain, swelling, bruising 2 days post vaccine continuing to present day of 6 days post vaccine: itching, with new redness and mild swelling at injection site
Teeth are painful; Talking funny like wants a cigarette when he hasn't had any for years; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Teeth are painful), FEELING ABNORMAL (Talking funny like wants a cigarette when he hasn't had any for years) and PYREXIA (Fever of 102F) 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.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced TOOTHACHE (Teeth are painful), FEELING ABNORMAL (Talking funny like wants a cigarette when he hasn't had any for years) and PYREXIA (Fever of 102F). At the time of the report, TOOTHACHE (Teeth are painful), FEELING ABNORMAL (Talking funny like wants a cigarette when he hasn't had any for years) and PYREXIA (Fever of 102F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 102f (High) patient had fever 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines blood thinners  Treatment information was not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Cellulitis at vaccine site. Tx with Augmentin and Benadryl.
Extreme soreness at injection site, couldn't move arm, bulging out swelling, redness, burning, itching, fever, headache.
Nerve tingling at all sites from bottom of feet to scalp after first dose of rabies shot - ongoing.                                      Now new onset progressive bilateral tinnitus (approximately 2 months after first dose)with inability to sleep even with OTC sleep aids.