chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose was taken 14 days after 1st dose; Headache; Body aches; A spontaneous report received from a consumer concerning a 48-year-old male patient who received the second dose of Moderna COVID-19 vaccine and second dose was taken 14 days after 1st dose and experienced headache, and body aches.  The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    Patient received 1st vaccine on 29 JAN 2021 (Lot number 029L20A)  and had no symptoms.  On 11-FEB-2021, the patient received the second of two planned doses of mRNA-1273 (Batch #: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the second vaccine on 11 FEB 2021 and reported the development of headache, and body aches. Patient stated having been told by his employer that he needed to take the second dose. Patient realized after receiving the second vaccination that maybe he took the second dose too early. Second dose was taken 14 days after 1st dose. Treatment for events included naproxen .  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event headache, and body aches, were unknown at the time of this report. The outcome of event second dose was taken 14 days after 1st does and experienced was considered resolved on 11 FEB 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #029L20A, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
While on a tour to PRIVATE I contracted COVID on or about August 7, 2022. Upon arriving in PRIVATE on August 9, 2022, for another tour in PRIVATE I became very sick with sneezing, runny nose, sore throat and dry cough. My spouse went to a local pharmacy and purchased OTC meds for my symptoms plus 4 home-style COVID antigen testing kits. I tested positive, and reported same to our tour company and to the hotel.. The tour company canceled our tour and the hotel accepted our request to remain longer in our assigned room (for up to 7 day, with no daily service and meals only by Room Service. The hotel also arranged for a nurse from a local medical facility to come to our room on August 10th.
Stiffness and redness about 2 inches around the shot location, hot to touch, and itchy. Started at about 7:30am 7 days after the vaccination took place.
I had travelled, when I came back I on Tuesday I tested using a home COVID-19 test it came back negative. I developed a cough so I tested again, this time it came back positive. I called the telemedicine at my doctor's office, he told me what to watch for and I did ask about the Paxlovid. They felt that I was not at risk but I was prescribed Albuterol Inhaler and Methylprednisolone (I chose not to take because of the side effects). I had a weird rash that has since went away, so has the stomach ache, I have a small lingering cough.
Patient developed nausea and vomiting earlier the day of 28 Nov 05.  ER visit on am of 29 Nov 05.  Patient given IV analgesics, antiemetics,a nd IV fluids; diagnosis of volume depletion and viral syndrome.  Patient discharged to home.  Lost consciousness at home and fell off bed.  Transported to ER and intubated by EMT.  Patient is currently an inpatient at hospital. Information from Medical records states cough,myocarditis, cardiovascular disease. Mechanical ventilation & ICU.  Tx w/IVIG.  Feeding tube.  Slow improvement & transferred to inpatient rehab. Discharge summary states Guillian-Barre syndrome, myocarditis, apnea, pneumonia.
Patient noted beginning to feel a headache, dizziness, itchiness and scratchiness of throat and mild throat tightness at 9:27A. Vital signs were done and a brief history was taken. Patient reported history of tension headaches, and hay fever. Patient reported that she has had mild allergic reactions to soy, bananas, and cantaloupe. Patient reported that she take Claritin, Flonase, and anti-histamine eye drops every morning for allergy management. Patient denies history of diabetes, any cardiac related issues, and any other chronic conditions.  Vital signs taken at the 9:31A, 9:46A, and 10:00A. At around 10:05A, Patient was taken to a private room to provide education for epi-pen use. ER precaution reviewed with patient and patient agreed with the plan of care. Patient verbalized understanding to seek care and medical attention should breathing become more difficult, the headache get worse, and if other symptoms worsened. Patient left the clinic to go to the pharmacy at 10:15A. Patient will pick up Epi-pen and then head home.
Did not advance needle far enough into deltoid during first administration; some of the dose fell out onto the skin. A second dose was then administered with no leakage.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number tm449, expiry date 2nd June 2023) for prophylaxis. Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis. On 26th April 2022, the patient received the 1st dose of Shingrix and COVID-19 VACCINE MODERNA. On 26th April 2022, less than a day after receiving Shingrix, the patient experienced fatigue, light headedness and blurred vision. On an unknown date, the patient experienced injection site erythema. On 27th April 2022, the outcome of the light headedness and blurred vision were recovered/resolved. On 30th April 2022, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the fatigue, light headedness, blurred vision and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 6-May-2022. Reporter's comments: The patient received Shingrix and Moderna COVID-19 booster on same day but at somewhere else. After receiving vaccines, on the same day, the patient experienced fatigue, lightheadedness, blurred vision and redness at the injection site. She had fatigue for 4 days, lightheadedness and blurred vision for 1 day and redness for an unknown amount of time. All symptoms were resolved. The reporter did not consent to follow-up. It was unknown if the reporter considered the fatigue, light headedness, blurred vision and injection site erythema to be related to COVID-19 VACCINE MODERNA as well.
severe arm pain redness swelling and heat, Itching at injection site .  Nausea began aprox 1 hr after injection then severe headache, fever of 100.1 and chills progression aprox 5 hr after injection. Nausea with 2 x emesis aprox 9 hr after injection. continuing muscle acheing and abdominal pain aprox 14 hr after injection
Patient developed sudden onset hearing loss and tinnitus in right ear 1 week after receiving first dose of Pfizer vaccine. No prior h/o ENT pathology, no trauma or antecedent illness. He was seen by ENT 5/6/21 where physical exam was normal, all cerumen removed, was given prednisone burst as follows prednisone 10 mg 6 tabs by mouth daily for 7 days, then 5 tabs by mouth daily for 2 days, then 4 tabs by mouth daily for 2 days, then 3 tabs by mouth daily for 2 days, then 2 tabs by mouth daily for 2 days, then 1 tab by mouth daily for 1 day.  This did not improve symptoms of tinnitus/hearing loss. On 4/30/21 intratympanic steroid injection performed right ear: " Via the anterior inferior quadrant, about 0.2mL of dexamethasone 10mg/mL was injected into the middle ear with good filling." Again he noted no improvement of symptoms. Will repeat hearing test in 6 months, tinnitus/hearing loss is stable at the moment.
LEG PAIN; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious.
3 1/2" x 3 " area of pink surrounding injection site, no induration, no pain. Scattered urticaria & welts over trunk, arms, legs, face & head.
Problem with her voice; started losing her voice; She feels like something is stuck in her throat; her voice is still harsh; This is a spontaneous report from a contactable consumer or other non HCP (Patient).  A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0173) as DOSE 1, SINGLE (at the age of 43-years-old) for covid-19 immunisation. Medical history included ongoing cholesterol, ongoing bones (bone disorder), ongoing headache and asthma from an unknown date and unknown if ongoing. Concomitant medications included pravastatin taken for blood cholesterol, meloxicam taken for bone disorder and propranolol taken for headache, all concomitant start and stop date were not reported. The patient experienced problem with her voice; started losing her voice on an unspecified date (after 45 minutes or half an hour after first dose). The patient stated she woke up, her voice was still harsh and she feels like something was stuck in her throat on an unspecified date. The patient stated, she usually takes medicine and I didn't take the medicine yesterday and today as was scheduled for first shot. The patient had asthma and had inhaler, but she hasn't taken nothing (Further clarification was unknown) and she haven't took nothing. The patient wanted to know can she take medication now and was this normal as the patient voice to be like this. The patient underwent lab tests and procedures which included blood work: normal on an unknown date of 2021. The patient did not received treatment for the events. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
I developed Kienboch's Disease.  I'm reasonably sure this had nothing to do with my vaccination.  I've been in a splint on my right wrist for 8 weeks or so.  It was diagnosed by MRI.  It was quite painful at the time of diagnosis but it feels much better now.
Back pain, severe leg pain (muscle pain) , patient wobbles when he walks. Lethargy.
5 days after immunizations developed papular erythematous rash, itchy, on arms, trunk, and 6/1 - worst on inner thighs.
Allergy to vaccine; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (BNT162B2), first single dose intramuscularly on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation.  Medical history included inflammation and immune system attacks itself. The patient's concomitant medications were not reported. The patient previously used diphenhydramine hydrochloride (BENADRYL), calcitonin, losartan, smallpox vaccine. The patient experienced allergy to vaccine on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Pt reported 35 days post vaccination that she had been diagnosed with chickenpox. Zosters cover body, concentrated on trunk, non-febrile. Treating with antihistamines.
Right upper thigh tense/tight and swollen. No redness. Pt limping, not bearing weight on right leg. Taken to ED and assessed. Told it was a reaction to flu vaccination and told to take ibuprofen and TYLENOL.
Narrative:  67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm.
Vaccine was received in left arm on April 8 2021. April 15th, one week later,  I started noticing my arm was itchy in the area where I got the shot. In the evening I noticed raised bumps in a form of a circle about 2 inches round. By morning, April 16, the bumps had gone down, but the circle filled in and now is all pink/red. The rash is itchy and once in awhile I feel a sting but mostly just itchy.  Found an article online that mentions this is something that some people are starting to see with Moderna vaccine. No treatment done yet.
She couldn't move her arm the next day and only took 1 advil. She iced it 10/23 and has noticed slight improvement.
RED, HOT, SWOLLEN (INDURATION 6 CM), PAINFUL. BLISTERLIKE W/O FLUID. WARM COMPRESSES AND ICE ROTATING A COUPLE TIMES.
patient felt dizzy and lay down on the floor about less than 10 minutes after receiving Covid-19 Janssen shot. Patient was immediately attended to by pharmacist . Patient never lost consciousness and she was aware of her situation. Patient was given a bottle of water but she refused. Pharmacy immediately called 911 and right after notified market director. Patient blood pressure was taken (116/85 mmHg heart rate at 85).  after laying done for approximately 10 minutes, she wanted to get up and she sat on a chair. By that time, emergency crew got to her and her vitals taken and were normal but they asked her to go to their ambulance for monitoring her heart and she can decide to go to the hospital, if she wishes. She was able to stand up and walk to the ambulance.  She was in good spirit when she was leaving and pleased that the pharmacist did not leave her alone at all time.
Shingles on right arm and hand starting 2 days after vaccination; treated with valacyclovir
Patient's mother called reporting that patient's arm was red and swollen. It started the day after the vaccination was administered. The patient also received dose #2 of MMR in the right arm that same day. The mother denied any systemic reaction such as hives or SOB. The patient complained of discomfort but not having high fevers. She was given tylenol for pain and warm compresses.  The mother described the swelling from her left upper arm extending close to her elbow. Father provided a photo which confirmed this. Patient advised to continue tylenol or motrin. Dispensed benadryl suspension to father. Reviewed allergic reaction red flags. Today, patient's father reports that all is resolved.
pt said her arm broke out with blood splotches or petechiae randomly down her whole arm. She stated she has this happen often due to various causes.
Vaccine was given to person under the age of 18. Screening measures have been reinforced to prevent continued vaccination under the age established .
Immediately following IM injection of Flulaval 0.5cc to left arm the participants injection site had localized swelling of approximately 1 inch x 0.5in. Asked participant to remain in room for monitoring. Offered ice pack for the area and the participant refused. She returned to work after approxmiately 5 minutes. Condition unchanged. Checked participant again at 9:00 AM and 9:25 AM. Participant still experiencing swelling and tenderness. Advised to seek medical attention if condition worsens.
patient states homicidal and suicidal thoughts. She has no history of depression or mental illness. "Never felt like this before."
Patient felt like back of tongue swelling and itchy ~ 15 min after administration  Patient received 12.5 mg Benadryl, 125 mg soul-Medrol in ED Sent home with an epi pen and steroids x 4 days
rash on her arms, which has now spread to her neck.; Dose 1 of Shingrix was given 14 months prior; This case was reported by a consumer via call center representative and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 14 months prior from the date of reporting ).   On 5th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th February 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 12th February 2020, the patient experienced rash. On an unknown date, the outcome of the rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The patient reported that she had dose 2 of Shingrix.  no events were noted with dose 1.  The patient reports that 7 days after dose 2, she developed a rash on her arms, which has now spread to her neck. The interval was more than recommended, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The reporter had no other contact information for physician at time of report.
weakenss in both legs, taken to ER seen by MD approx 10AM 21JAN92 MD dx vax reaction;
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 28-Jun-2023, 5 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 37th patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:MASTER CASE
I had my last booster in September, which was Pfizer, and all the other vaccines were Moderna. I started having very mild cold symptoms. I took a COVID-19 test on Tuesday and then Thursday I took a COVID-19 at home test. On this day I called my doctor, and I was given PAXLOVID, and I took it for five days, and then on Christmas Day I had a belly ache. I started to vomit blood in big amounts then this happened repeatedly for the next 4-5 hours and then I stopped. The next day I was very weak, so I called my doctor that was listed but nobody was in the office because of the holiday. I called the doctor and reached them on December 27, I was then sent to have endoscopy surgery. I then started the recovery process.
Burning sensation on stomach Felt like sunburn but without redness or rash two weeks later bumps formed Clinic diagnosed as shingles Was prescribed Valacyclovir Medication dose will end May 2 I am due for my second dose May 3.  Am wondering if the shingles will interfere with the second dose or should I reschedule
Rash at site and joint pain and stiffness in hands and wrists.  Lasted 3 days, severe, problems typing, using hands.  Slowly resolving.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890: