chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public). At the time of the report, ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received contain no new information.
Patient experienced light headedness and symptoms consistent with syncope, as well as nausea. the syncope event occurred in the chair without a fall.  per patient reporting patient had not eaten 8 hours prior to administration time and also experienced anxiety with vaccines. patient was given supportive care including assisting to the floor carefully with a pillow provided and feet elevated. patient was also provided with juice to support any potential low blood sugar.
11/02/11 I had to take him to the ER after finding blood in his diaper. We cloth diaper, so I was able to tell that this was from his penis. Blood in the urine. We left with no answers. This happened three more time before November 20, 2011.  November 20, 2011 he spiked a fever of 102 that wouldn't budge no matter what I did.  November 21, 2011 we had to go to the ER in the night again as his fever reached 104 (this was just from touching his skin, he wouldn't let me put it in his mouth). It was 104.4 at the hospital. They diagnosed him with a double ear infection. He had never had an ear infection before.  December 2nd, 2011 we noticed a few weird blue/purple spells over the last week, turning up on his hands, feet, legs, mouth, and lips - just happened in the morning almost daily. No one could give us answers.  December 6th, 2011 I figured out he has a dairy allergy. A future appointment with a pediatric specialist would confirm this. I hadn't noticed this issue until after these vaccinations.
Arm is hurting; Arm ache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache for a few days) and PAIN IN EXTREMITY (Arm is hurting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. NDC number 99) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm ache for a few days). On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is hurting). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm ache for a few days) had resolved and PAIN IN EXTREMITY (Arm is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
I had a fever of 102.6. The injection site swelled up and got infected. I developed cellulitis.
patients mother stated he developed a large dime sized red whelps around the injection site and his back.  She took him to his provider which told her it was common symptoms and it will go away.  Patients mother disagrees with this since the red whelps are now spreading to his torso and buttocks along with tiny blisters that have white heads .  These spots come and go  and he still has them at this time.  She will follow up with his Pediatrician.
On the morning of 10/10/2022, patient developed extreme fatigue.  By early afternoon, she was in extreme pain in her upper right chest area.  The PCP recommended going to the nearest emergency room.  We arrived there shortly after 3:00.  Around 6:00 she received tests to determine the source of the pain, including a CAT Scan and a test for DVT.  DVT was not found, but a pulmonary embolism was found in the right lung.  She was started on heparin and admitted.  She was released Wednesday, October 12.  She is home and has improved, and is now on Eliquis 5 mg 2 times daily and 1,000 mg Tylenol daily.
Bursts of chaotic heartbeat 3 days after first shot.  Random "burning"  pain in chest.
Soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's (Sjogren's (kind of a lupus)).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        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.   No Concomitant product use was reported.  The reporter stated that the patient received their first dose on 03-Mar-2021 and experienced soreness in the arm. It was also reported that the patient had preexisting medical condition Sjogren's (kind of a lupus) with unknown onset, but the patient confirmed it was prior to the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-456751, MOD-2022-456752 (Patient Link).
So I thought maybe I was having a blood shot eye almost immediately after I noticed it and it went away and than next I had a dry throat and tightness in my chest, I had a dry cough and I could tell my throat was more painful and I had congestion and I did a home COVID-19 test right away and it was positive. I also had stomach bloating and pain and I messaged my Dr, and she called me back and prescribed me Paxlovid. I have had gas and some aches and my feet even ache and where they have ached has now got bruises and the congestion seems to be getting better but I have had to take decongested for it but I have to limit that due to my allergy of antihistamines. I have had headache, hoarseness and now I have a progressive cough and I been tired and have not been able to sleep so I thought maybe that the Paxlovid maybe causing me not to sleep. I think I got it when I bumped my eye when I took my father to the Dr. office.
On 09Feb2021 I got COVID; had the Pfizer shot 22Jan2021. On 09Feb2021 I got COVID; really sick; sore arm; This is a spontaneous report. A 72-year-old female patient (patient herself) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262, Expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 22Jan2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 72 years). The patient's medical history included ongoing colitis ulcerative. She was also immunocompromised with ulcerative colitis (but not that immunocompromised; it's in remission), pulmonary embolism, have a history of blood clots in her lungs, migraine prophylaxis, Prophylactic migraine headaches, migraine. Concomitant medications included Topiramate (TOPAMAX) taken for migraine prophylaxis, migraine. The patient previously took Pneumococcal vaccine and experienced Guillain-Barre syndrome. On 09Feb2021, patient experienced three days before her second dose was due, she was tested positive for the COVID-19 virus. On 12Feb2021, she was also on oxygen and nebulizers during that time. On an unspecified date in Feb2021, the patient had experienced really sick and sore arm. The patient underwent lab tests and procedures which included antibody test: 750 on an unspecified date and SARS-COV-2 test: positive on 08Feb2021. Therapeutic measures were taken as a result of events includes an antibody infusion of Bamlanivimab on 12Feb2021, Dexamethasone and Ivermectin. The seriousness of the events really sick and sore arm was non-serious and for the all the other events was serious and medically significant. The outcome of the events was unknown.      Follow-up (01Sep2021): Follow-up attempts completed. No additional information was received from last follow-up attempt.
feeling exhausted; This spontaneous report was received from a consumer via company representative referring to a male patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was received the second dose of zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient experienced fatigue.      The outcome of fatigue as well as its causal relationship with the vaccine were not reported.
hives/urticaria; itchy neck that migrated to body in patches; Hot; not pleasant; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F22A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for an unknown indication.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant). The patient was treated with PREDNISONE at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant) outcome was unknown.            It was reported that 11 days after the booster, patient experienced hives, urticaria, itchy neck that migrated to all her body in patches, hot, not pleasant. Patient's doctor prescribed prednisone and Claritin for about a week which has helped and patient has tried over the counter lotions.
About 3 1/2 hrs after receiving vaccines, pt had an episode of projectile vomiting, became pale, limp and listless. Lasted about 10 minutes, until paramedics arrived.
This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown demographics. No medical history was reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose and frequency unknown) (Lot no: L015049, Expiry date: 29-APR-2017). No concomitant therapy was reported. No adverse effects reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
patient presented to emergency department on 1/5/22 with chest pain and shortness of breath patient was admitted for further management of acute chest pain patient was found to be covid-19 positive on 1/5/22 patient did requirement treatment for symptoms associated with covid-19 infection. treatment included remdesvir patient was discharge to home on 1/11/22
Bell's Palsy- steroids, Valtrex, speech therapy. ongoing left facial paralysis
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: wag19821), on 06Mar2021 as dose 2, single (Lot number: wag19821), on 07Oct2021 as dose 3 (booster), single (Lot number: wag19821) and on 15Apr2022 as dose 4 (booster), single (Lot number: wag19821) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "lastose allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: It was reported that after treatment ended, virus came back, still fighting it 2 weeks later.
Patient experienced vomiting, diarrhea, sharp urinary pain. Lasted 24-36 hours without any medical treatment.
Narrative:  96yo male patient died on 1/28/2022 at nonfacility hospital (Hospital). Pt was admitted to Hospital on 1/18/2022 and tested positive for Covid on 1/19/2022. Pt had received covid vaccines on 2/3/21, 3/4/21. Vaccine failure lead to covid infection & pt's death.
Fever 100.3, swollen lymph node under armpit on injection site for 5 days, body aches, tiredness lasting 3 days
pfizer vaccine kept frozen more than the approved 14 day interval before thawing to administer.
I had upset stomach; diarrhea; Nausea; I don't feel well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EW0185) via unspecified route of administration on 25Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Lot number: EW0161) on 04Jun2021 for COVID-19 immunization. It was reported that patient had a couples of side effects four days later. I had upset stomach, diarrhea for 1 day in Jun2021 and then 8 days later Saturday it began with yesterday in particular and today a lot of nausea in 2021 and you know, yeah and I am taking something over the counter stuff called Tauzin (Treatment) which may be helpful little bit." I want to know if that's okay. Consumer stated "I don't feel well in 2021. It's hard for now." The outcome of event diarrhea recovered in Jun2021, while for other events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient tested positive for covid on 01/12/2022.  Was admitted to hospital on 01/14/2022 with symptoms of muscle aches, cough, nausea/vomiting, headache and dizziness.  There is no pre-existing conditions listed.    No discharge from hospital date given.
her breasts feel like burning when eating spicy food; thinks the burning sensation is due to her lymph nodes being affected; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 31Jul2021 (age at vaccination was 51 years) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing blood pressure high and lumpectomy (She had surgery. She had a lumpectomy in her right breast like 5 years ago and she felt in more in that breast more so). Concomitant medication included atenolol, chlortalidone (ATENOLOL CHLORTHALIDONE) taken for blood pressure high. No other vaccine was administered within four weeks prior to the first administration of COVID vaccine. The caller stated that she only had one shot and she never had, only one vaccination for COVID and no other vaccine. The caller stated she got the shot of the Pfizer Biontech COVID vaccine last Saturday. She said her breasts felt like burning when eating spicy food on an unspecified date. She noticed last 2 times she had something spicy her breast started burning inside. Every time she eats some spicy her breast hurts. She asked if that was normal. She never had this before her whole life. The caller said she was aware that the Pfizer Biontech COVID vaccine affects mammograms and it does something to sonograms as well. The caller asked if it had something to do with her lymph nodes because she thought the burning sensation was due to her lymph nodes being affected on an unspecified date. She stated that she knew it does something to the women's lymph nodes that's why she wanted to know what the problem was. The date of second shot was reported as 21Aug2021. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
After I got the shot I could feel it going into my system (histamine).  I had myalgia on my right shoulder and up into my neck, those I felt first.  I felt like a histamine release. It is like I felt a drug being released in my body, a strange feel. Made me feel woozy. Not a major reaction, no airway constrictions, just felt uneasy. As I was walking to my vehicle to leave the hospital my arms started feeling tingly so I decided to walk to the ER and get checked. Vitals were taken and a shot of Benadryl - 50mg, sat around until it kicked in about 30/40 min and it made the symptoms subside. Next morning I felt fine , arm was sore from the injection but that was all.
By 10:00 pm that evening I got Chills, fever, muscle aches, headache, nausea and low back pain.  Stayed home from work for 1 or 2 days.  Felt better in all ways except my low back got very, very painful.  I asked my wife to buy me a walker to take to work because I had difficulty walking the distance from the parking lot to inside my office.  Also used the walker at work.  My boss said to go home, it looks like you're in  pain.  Saw Dr. on Monday March 15 because the low back was getting worse.  He prescribed muscle relaxors and anti-inflammatory medicine.  Called the next day asked for something stronger for pain because worse.  Nurse responded to continue on existing meds.  Went to Chiropractor on both March 16 and 18 without back pain relief.  On March 19 went to urgent care, got X-ray and pain meds.  MRI done 2 days later on March 21st which revealed a spinal abcess. Admitted to Hospital, surgery done to remove spinal abcess on March 22.  Bacteremia, laminectomies in L3,4,5 S1 to relive spinal cord pressure.  Puss had the filled spinal epidural cavity, cultured out as Strep bacteria.    Remained hospitalized until April 2nd. Sent home for 1 night then returned to hospital via ambulence the next day April 3rd with 103 degree fever.  Discharged April 8th. Readmitted to hospital for 3rd time on April 17 where I remain today with Kidney and liver function problems likely reactions to meds.  Continue to have excruciating low back back which is why continues to be hospitalized at the time of this report.
no adverse event as of this time.  reported to Public Health office. wrong dilution of vaccine ( 1.3 ml vs 1.8).  monitor only, no treatment at this time
muscle pull; sore in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle pull) and ARTHRALGIA (sore in shoulder) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METHYLPREDNISOLONE, LOSARTAN, METOPROLOL, WARFARIN and ROSUVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Mar-2021, the patient experienced MUSCLE SPASMS (muscle pull) and ARTHRALGIA (sore in shoulder). At the time of the report, MUSCLE SPASMS (muscle pull) and ARTHRALGIA (sore in shoulder) outcome was unknown.            Treatment details included Methylprednisolone.
Lightheaded, nausea, flushing, metallic taste, tingling on upper lip area, seeing white spots, pt sat down and took deep breaths and felt better within 5 to 7 minutes.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 87-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.