chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 hr after receiving vaccine pt c/o feeling dizzy then in the next hr started wheezing and developed hives on upper body. Also had stomach pain. Pt gave self BENADRYL and used ALBUTEROL inhaler every 2-3 hours. She was feeling fine by 00:00. I gave FLUZONE at 14:30.
Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose; He had fever for 2 or 3 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose) and PYREXIA (He had fever for 2 or 3 days after the 1st dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (He had fever for 2 or 3 days after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose). The patient was treated with IBUPROFEN (ADVEL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (He had fever for 2 or 3 days after the 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Spanish speaking caller received the 1st dose of the Moderna vaccine on 10Apr2021 and hasn't received the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Dose of vaccine which were not stored at recommended range was administered; This spontaneous report was received from the administrator, and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 18-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S025155, expiration date 13-AUG-2021, once (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature above 47 degree fahrenheit (71.92 F) during 4 hours and 55 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.  This is one from several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA010653:
cold sore appeared in nose, lower lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore appeared in nose, lower lip) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sore appeared in nose, lower lip). The patient was treated with DOCOSANOL (ABREVA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sore appeared in nose, lower lip) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 11/5/18 patient came into the pharmacy requesting to get a flu  shot and the pneumonia shot. She got PNEUMOVAX 23 NDC 00006-4837-01 and FLUZONE HD NDC 49281-0403-88. Both were in her left arm (FLUZONE upper and PNEUMOVAX lower). 11/10/18 patient came complaining of redness, swelling, and occasional pain that is shooting down into her hands. She said that the symptoms are improving versus getting worse the last couple of days, but that it is more comfortable to have her arm bent versus having it hanging straight. I recommended that she try using OTC Pain Relievers or a cold compress to help with the symptoms and to follow up with her PCP if her condition worsens.
First day severe fatigue muscle aches. Second day 4/24 temperature 101.3, severe pain , muscle pain , chills, nausea, lack of appetite, severe fatigue, groggy, weak, severe headache and joint pain. 3rd day 4/25 woke to large grapefruit sized red spot on my arm that was hard as a rock covering almost my entire upper arm. However fever is now down to 99 and chills gone.
was given the vaccine behind my deltoid in the fatty part of my arm; had severe left breast pain radiating to my back accompanied; shortness of breath; had severe left breast pain radiating to my back accompanied; This is a spontaneous report from a contactable consumer (nurse and patient herself). This female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on an unspecified Sunday at 12:00 as single dose behind her deltoid in the fatty part of her arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The question is the patient received the second shot of the Pfizer vaccine Sunday at 12:00, was given the vaccine behind her deltoid in the fatty part of her arm. She had severe left breast pain radiating to her back accompanied with shortness of breath since Tuesday morning. Patient wanted to know if that side effect has been reported with vaccine. Was the vaccine given this way considered to be effective? Response included Off label disclaimer provided. Pfizer is unable to make recommendations for individual patients who received an invalid vaccine dose; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken. As per CDC guidelines if the vaccine was given via an incorrect route (e.g., subcutaneous) Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events. Informed caller the only side effects that has been reported with the vaccine is difficulty breathing but that's secondary to a severe allergic reaction which generally occur within few minutes to an hour post vaccination. Reporter asked if Pfizer refund medical expenses, response included Program program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Events were reported as non-Serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Then it went away. Then she started to experience the headache again today; Headache; Nausea; Vertigo; Fever; Feel bad; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, in arm left, on 26Jan2021 at 3:15PM (at the age of 74 years), as a single dose for covid-19 immunization. The patient medical history included she had the flu shot, but believes it was a month or two ago prior vaccination within 4 weeks and concomitant medications were not reported. She stated she take a lot of pills. She has morning and night pills. There was no history of previous immunizations with the Pfizer vaccine that considered as suspect. There was no additional vaccine administered on same date of Pfizer suspect. She had the first shot on 26Jan2021 (Tuesday), and she felt okay the day of and then on 27Jan2021 (yesterday) she started to feel bad. She had a headache, nausea, vertigo, and fever. Patient stated that she did not wake up with it or anything, she noticed it around lunch it was not real bad. Then it went away. Then she started to experience the headache again on 28Jan2021 (today) around lunch. She still currently has the headache, but it is minute/slight. She has nausea and vertigo. It was real bad last night. She had some Dramamine and took it for the nausea. The nausea and vertigo is not as bad now. She stated that she is assuming these side effects are from the shot, it is such a coincidence. She is questioning if these events are from the shot. The patient underwent lab tests which includes Body temperature of 100.1 on 27Jan2021 that evening and the last temperature reading she took was 99.8 on 28Jan2021 (Today). Outcome of the events headache, nausea, vertigo, and fever was reported as recovering and Feeling bad, Disease recurrence was reported as unknown.  Follow-up attempts have been completed and no further information is expected.
Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; Rash to anterior neck, 10x10 cm, raised, red, itching.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in the left arm on 30Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included ovarian cancer and chemotherapy; both  from 2018 to an unknown date. The patient's concomitant medications were not reported. The patient has not received other vaccine in four weeks. On 01Feb2021 10:00, patient experienced rash to anterior neck, 10x10 cm, raised, red, itching. Outcome of events was recovering. Therapeutic measures were taken as a result of events includes Claritin, steroid and antihistamine. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
It was reported that a 45 year old female received Fluzone 98-99 on 10/9/98. Reportedly the pt experienced hives.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2022 at 15:00 as dose number unknown, single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Compazine, reaction(s): "Known allergies: Allergic to Compazine", notes: Known allergies: Allergic to Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2weeks: No, Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date- 15Jun2022, Treatment stop date- 16Jun2022, Indication: Treatment of COVID-19.  Adverse event: Paxlovid severe diarrhea within 20 minutes of eating anything. Her doctor told her to stop taking it immediately. Known allergies: Allergic to Compazine  Follow-up attempts are completed. No further information is expected.
Information has been received from a practice manager and a healthcare worker, concerning a patient of unknown age and sex. On 30-AUG-2012, the patient was vaccinated with a dose of VARIVAX (merck) (dose, route and frequency were not reported) (lot#: 0140AE; Expiration date:10-JAN-2012) that was improperly stored in a refrigerator for more than 72 hours. There were no adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
10 days, post vax, had 1 vesicle on lower abdomen, approx. 2mm and 4 macules on cheeks and 1 on neck. Was seen for routine check-up and dx'd with side effect of varicella vaccine.
Redness, vesicles at vaccination site. No tenderness or pruritus. No systemic sx.
I received my Moderna COVID-19 Vaccination at approximately 0800 am on February 10, 2021. At approximately 1800 hrs the same day, I experienced a sudden onset of muscle spasms to my lower back. I was at rest, sitting in a chair at the time of onset. The muscle spasm to my lower back was extremely intense and I had difficulty walking. This continued for about 1.5 hours. Also, during this time, I experienced cramping to the arches of both my feet. This was intermittent. I also had pain/soreness to my hips bilaterally. After approximately 1.5 hours the lower back spasms and cramping to my feet subsided.  I do not have a history of lower back issues and this is my first experience of spasms of my lower back.
Developed COVID-19 symptoms on 5/14/2021 confirmed by PCR on 5/19/2021
soreness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 10:30 (Lot number: EW1058) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "back pain from back surgery" (unspecified if ongoing), notes: had years ago. Concomitant medication(s) included: TYLENOL.The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "recovering", described as "soreness of the arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: There are no other products no patient history. Reporter stated that, he got the vaccine last month (i.e., 06Apr2021) and he still has soreness of the arm. reporter stated that, the doctor told him that he could have side effects up to 6 months. Reporter stated this started with his first shot and continued when he got the second shot on 28Apr2021. Caller stated he still has pain in his arm and a little minor headache, but it is not serious and just wants to make sure this is safe. reporter stated the soreness of the arm happens off and on and is a little better. Reporter stated he has taken over the counter Tylenol and it helped a little bit. No Additional Vaccines Administered. There are no Prior Vaccinations within 4 weeks. Reporter stated he usually gets the flu shot and pneumonia shot around October or November.   No follow-up attempts are possible. No further information is expected.
7/3 eve of Inj. - numbness of lip, itching on upper right leg and testicular area, also on palms of hand, 7/5 chest and throat tightness with difficulty breathing.
Next day  and for 2 days after was fever chills, nausea, headache.    After 2 days was fine. 2 weeks later I got a sharp pain in right shoulder, abl Abou 1.5 weeks later got unbearable pain in left shoulder. Went to ER. Did blood test and scans said I had multiple blood clots in both lungs. Spent 4 days in hospital. Did a Doppler leg study and ruled out blood clot from legs going to lungs.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL (lot number K023432 and expiration date 18-JUN-2016, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2013US007858 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 06 Mar 2013. This reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.
Patient described the following: Lips swelling - Began the morning of 1/23/2021, self-resolved by the end of the day Rash on chest/face- Began the morning of 1/23/2021, was worse on 1/24/2021, then self-resolved on 1/25/2021 Body aches - Began the morning of 1/23/2021, self-resolved on 1/25/2021
Pfizer-BioNTech COVID-19 Vaccine EUA: During the administration of the vaccine, the vaccine leaker out. He was revaccinated immediately.
he came down with covid,virus; low O2 sats; getting sick; no taste/ loss of sense of taste; no smell/ loss of smell; muscle aches; low grade fever; Sore throat; Cough; This is a spontaneous report from a contactable consumer (patient wife). A 70-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261) via an unspecified route of administration in arm left on 26Jan2021 at 01:00 as single dose for covid-19 immunisation. Medical history included diabetes mellitus and asthma and concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus. On an unspecified date, the patient came down with covid virus and was quarantined. On 05Feb2021 he was getting sick, no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low grade fever, sore throat, 15Feb2021 with low o2 sats, on an unspecified date in Feb2021 cough. The patient underwent lab tests which included oxygen saturation: 88 percent on 15Feb2021 low, on room air. Prior to this they were 92 percent and was not tested for covid. Seriousness of all the events were resported as non-serious. The outcome of the events he came down with covid virus and getting sick was unknown. The outcome of the events low grade fever was recovered on 15Feb2021. The outcome of the events no taste/ loss of sense of taste, no smell/ loss of smell, muscle aches, low O2 sats was not recovered. The outcome of the events sore throat, cough was recovering.
Symptoms: 104.7 Fever, body aches, chills, headache, joint pain, fatigue. Sweating profusely at night.  Treatment: Tylenol and ibuprofen   Outcome: Tylenol would lower fever to about 100 degrees and then fever would come up again to 103 degrees  plus.
Significant local reaction, swelling, erythema, warmth, and inability to move R arm. Vaccine was given in the R deltoid.
Information has been received from a physician assistant referring to a 60 year old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 30-JUN-2015 the patient was vaccinated with ZOSTAVA vial (dose, frequency and route were not provided). The patient had no concomitant medication. On 30-JUN-2015, the patient developed pain at the injection site shortly after the administration on the same day. On 01-JUL-2015 ("yesterday"), the patient also began to experience erythema about 12cm by 6 to 8cm in size, warmth and tenderness at the injection site. No rash presented. On 02-JUL-2015 ("today"), the patient then came to the emergency department because he was concerned with the reaction. No lab diagnostics studies were performed. No treatment was given to the patient and he was discharged without being admitted to the hospital. The outcome of the events was reported as not recovered. Causality was not provided. Additional information has been requested.
She reports every time she bends over she gets dizzy and nauseous. Reports this happens when she bends over and states she feels she has been "drinking". Denies any fever or ill like sx.
Right as injection was going in I felt a rush of something up my arm, side of my neck and into my ear. Waited 15 minutes and I felt okay. But then I started having really weird symptoms had horrible, horrible cramps. I haven't had cramps in years (decades). It turned into every gland in my neck or body were inflamed and sore and I couldn't move. I was so sick. I went to my doctor and he could tell my glands were swollen on the left side they hurt but on the right side they didn't hurt but they were inflamed. I missed a week of work and I was so tired. So lethargic. Was just told that if my symptoms  worsened to go to ER. I did Tylenol, Ibuprofen and vitamins and I had to use a heating pad. I'm still at this time pretty tired all the time.
numbness in right side of face, weakness in both legs, right leg pulled to the left, feels unbalanced. Has been to the doctor twice since the vaccine for extensive blood work. Ruled out stroke.
On Jan 11,2021 at 6:30pm I became light headed and almost passed out. My heart rate was elevated felt like it was going to beat out of my chest. My breathing was heavy and short. I got chills and extremely weak and slight pain in my chest. I ended up going to Hospital by 6:45pm. The rest of that week I was super weak, nauseous, and threw up twice. The following week I was nauseous and weak and had heavy breathing on Friday January 22nd and ended up throwing up.  Then Thursday January 28th I became nauseous and light headed around 6pm. Friday January 29th around 6pm I was at work when I became extremely nauseous, light headed, and almost passed out. My heart rate was elevated and my breathing was again heavy and short and I had a pressure tingling pain in the left side of the back of my head as well as soreness in my left arm pit. I ended up going to Degraff Memorial Hospital by ambulance.
States child developed a fever that evening of 103 degrees. States had a slight cough and then later saw a visible rash on chest, back and legs. States child continue with a fever for several days and treated him with Tylenol every few hours. Mother did not seek medical attention or called her pediatrician. States did not want to go to ED on Saturday night because they would treat the child with Tylenol and release. Child was fussy but was always alert and drinking fluids well and urinating his normal amt. Child is awake, alert and cooperative. I was able to examine the rash which is on his face, back, chest, buttocks, upper legs. Rash are like tiny bumps, no redness or is not itchy and same size. Temp taken at clinic in ear was 97.6. Lungs are clear. Awake and alert and drinking orange juice from a sippy cup. States child has a fever for 3 days but did not recall how high it was since Saturday. States child cough up some yellowish phlegm a couple of days ago.
Within minutes after administration Varicella and Fluzone - patient was SOB, coughing, hives began on both thigh area and then redness over entire body chills, Benadryl 25 PO, Benadryl 25 IM and Dexamethasone 4mg IM, nebulizer with Albuterol and Pulmicort
Hives appeared after approximately 2 days after vaccination. Still having them - possibly - chickenpox.
pt recvd vax 17DEC92 & during the administration of vax pt devel a hot & burning sensation in lt ring & middle finger which lasted only a few seconds; 2 days later devel pain @ inject site;
Myalgia, Arthralgia, Fever, CoughWheeze, fatigue, chills Narrative:
This non-serious medically confirmed report (initial receipt 03-OCT-2014) concerns a 78 year old non-pregnant female patient. On the 26-SEP-2014, the patient received AFLURIA (batch number 10248111A) 0.5 ml annually. On the 26-SEP-2014, the patient immediately afterwards experienced a wheal at the injection site with redness and itching This spread to the rest of the arm and across the chest. The patient's primary health care provider was aware and the patient had returned so the reaction could be evaluated. Outcome was unknown.
I have had a bloody nose everyday since Monday, some days more than once, up to 3-4 a day.