chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient immediately felt a tingling sensation from the arm to her neck after dose given. Also reported migraine onset after dose and continued for additional 5 days. Patient also reported an increase in asthma exacerbations after the dose that gradually decreased in severity as the days progressed further from the day the vaccination was given.
sleep for 36 hours, then nauseas,  headache,  After that four 4 months no taste or smell  Terrible taste in mouth
I started to feel really tired. By 5PM I was so tired I wanted to nap. On Thursday I developed a cough and by Friday I woke up with a cough and my daughter indicated that it sounded different. I woke up Friday with pain in my ears, so I decided to complete an at home COVID-19 test which was positive. The cough got worse with a headache. I called my doctor and he prescribed PAXLOVID. I just rested. On Saturday the cough was much more pronounced. Yesterday I started to feel like I was over the worse part, but I am still very tired, and I still cough if I move much. I have a lot of postnasal drip and aches. I have not had a temperature so far.
After giving the vaccine to the patient, the Medical Assistant noted that the vaccine had expired on 1/30/2023.  Patient notified.  Pt to return in one month will revaccinate upon her return
Fluzone given IM left deltoid, temperature 98.6F, on 10/31/00, at 11:00. On 11/1/00, localized reaction at injection site with wheal 130mm diameter; red and warm. No medication needed. Duration of 4-5 days with complete recovery.
More frequent or extended migraine headaches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "More frequent or extended migraine headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately the time of my second vax, I experienced shortness of breath.  I exercise regularly and thought it might be related to anxiety.  The shortness of breath comes and goes.   I went to doctor and an EKG was done to see if it is heart related.  The EKG showed no problems, but the doctor has referred me to a cardiologist.
5/4/2021   Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms: very nervous, complains of itching to face and lips   Assessment : Time of assessment 1445. Alert and oriented and redness and visible stratching to face and lips.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  VS- BP- 155/83, O2- 100 % at 1445, recheck at 1455- BP- 135/90, O2- 99%, drinking water, 1510- BP- 133/91, P- 72, O2- 100 %, 1522- BP-144/101, 1549- BP- 138/88/ P- 71, O2- 100 %       Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 1505. Administered by RN. Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1522. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 1445 and 1455. Administered by RN.  Famotidine 20 mg 1  Po x 1 at 1518 by RN   Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 5/4/2021  2:35 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EW0167   NDC: 59267-1000-2          Electronically signed by RN at 5/4/2021  4:40 PM  Immunization on 5/4/2021   Detailed Report  Note shared with patient
Chills; Fever; sick all night; him not feeling well; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included illness from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced chills, fever, sick all night and was not feeling well. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Per patient wife ; Rash with blisters associated with burning and itching on butt, arm , back
Started menstrual cycle 3 weeks early; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Started menstrual cycle 3 weeks early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Aug-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021 at 10:00 AM, the patient experienced POLYMENORRHOEA (Started menstrual cycle 3 weeks early). At the time of the report, POLYMENORRHOEA (Started menstrual cycle 3 weeks early) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received on 13-AUG-2021 included contact information.
April 12, 2021 4:00am  Intense Chill until passed out. 7:00am Woke up with body boiling. High fever. Until passed out. 7am-2pm cycles of intense chill and high fever 2:00pm Small amount of water intake. Realize Extreme arm pain. Took 2x advil. 7:00pm Woke up in soaking sweat. Drunk can soup. Took a shower. Chill came back after shower. 7pm-4am(April13, 2021) Cycles of moderate chill and moderate fever with fever. April13, 2021 Muscle soreness, tiredness, brain fog, lack of appetize, bouts of cold sweat throughout the day.
After receiving the HPV shot my daughter has developed a huge lump under her skin that is hard and painful to the touch.
Headache, Myalgia, Diarrhea, numbness at injection site, fatigue Narrative:
Developed vaginal ulcers 48 hours after Moderna booster (4th shot).   Had received Pfizer for 1st, 2nd and first booster. Had vaginal ulcers after 2nd pfizer shot as well.
Became very pale, dizzy, had dry heaves, C/O extremities tingling brought to cot and lay down, VSS,O2 sat between 97-98%, was given water
Severe rash all over torso and going down my arms. Starting to go up my neck and down my thighs.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: pt came to pharmacy to pick up prescription and in passing mentioned that after his vaccine on 4/21/22 he could not raise his arm at all. Patient stated that his doctor told him it was the vaccine that caused this. Patient stated that he has been going to physical therapy and has regained some motion to left his left arm again.
The pt developed an "allergic reaction" described as injection site redness and swelling, with fever. A diagnosis of cellulitis was made and the pt was treated with a 17 day course of an unspecified antibiotic. No further infomation was available at the date of this report.
ADVERSE REACTIONS; This spontaneous report received from a consumer concerned multiple patients. 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 not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421103.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sore arm for 2 days at injection site then went away. 1 week later, injection site warm top part of arm and raised bump where believe injection was
Tingling in hands and legs. Weakness and loss of movement. Trouble breathing, trouble walking, eating. Loss of bladder control. Burning of hands, legs, back.
Havent been able to getout of bed; My head hurts; Terrible sore throat; No appetite; Fatigue; Chills; Muscular pain; Feeling very sick; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 31Mar2021 at 11:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no.  The patient had no known allergies to medications, food, or other products. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient was tested for COVID-19. On 05Apr2021, the patient had nasal swab COVID-19 virus test and the result found to be unknown. The patient received the vaccine on Wednesday 31Mar2021, and started feeling very sick since Friday 02Apr2021. On Monday 05Apr2021, the patient was feeling as sick, it had not gotten any better, and was not been able to get out of bed. The patient's head was hurting, a terrible sore throat, had no appetite, fatigue, chills and muscular pain.  Muscular pain was the only symptom that was getting better. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events malaise, bedridden, headache, sore throat, appetite lost, fatigue, chills and muscular pain was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 014M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.            No concomitant medications were reported.  Patient did not seek to medical care due to adverse events. Patient was experienced a similar event in past.  No treatment medications were reported.   This case was linked to MOD-2022-545402, MOD-2022-545345 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Contained no new information.
choking; Burping after the first dose; Hands and face red; Hands and face swollen; Hands and face swollen; Anaphylactic shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOTIRON), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved.  The patient reported having anaphylactic shock after receiving vaccine on 12-Mar-2021. Patient reported burping, hands and face red after reaching home about 45mins after receiving the first dose and was rushed to Emergency room where the patient experienced choking and swollen hand and face.  No corrective treatment was provided.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-209375 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sometime in October I seem to be having heart palpitations. I mentioned it to my PCP at that time and was advanced to reach out to my cardiologist. It took a while to get an appoint I was seen on 01/27/2023. He did an EKG and told me I had Atrial Fibrillation. He had looked at a previous EKG of Aug 2002, and saw no sign of this. It shows a month before the vaccine I was fine. He scheduled me for a eco cardiogram three days after that and started me on two medications, Eliquis and Metoprolol. During our discussions I mentioned I had EPI diagnosed because of COVID-19. He mentioned that the vaccine prior to that could be the possible cause for this. I have this issue now and I believe the medication is helping. I was healthy before this, had not seen a Cardiologist in ten years. As part of treatment the doctor suggested I have a Cardio Version done.  I had that done this past Monday.  It was the thought that it wouldn't help long term but it possible could. It was lowest risk to try before any other treatments. I have evaluation Monday with results to know how this helped if at all.
Information has been received from a registered nurse concerning a 72 year old female with hypothyroidism who on Nov 29 2005 was vaccinated with intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant therapy included vitamins (unspecified), calcium (unspecified) and levothyroxine NA (Synthroid). Within 12 hours of vaccination, the patient called the emergency room complaining of red, swollen, and tender to touch right deltoid. The pat6ient was instructed to take fexofenadine (Allegra). No laboratory or diagnostic test were performed. By the next day, the redness was almost gone, and it was slightly tender. Within 36 hours, the patient was back to normal. On Dec 1 2005, the patient recovered. The reporter felt that the patient's peripheral edema, erythema, and tenderness were other medical events (OMIC). Additional information has been requested.
High fever (103) one day after vaccination but more concerning is that the arm swelled up, not at the injection site but lower in the arm in the posterior upper arm area. Also, severe pain under left arm and very swollen lymph nodes requiring Motrin to alleviate the pain. He also reported a bad pain shooting down the arm at the time of injection.
Was to give Pfizer second dose.  Accidentally gave Moderna.  So gave wrong medication and also early.  Did have employee stay 15 minutes after wrong dose and employee had no reaction to the Moderna injection.
Received pneumonia vaccine while in hospital 08/11/2003 for elective defibrillator replacement.  Had sore arm and some rigors, but discharged from hospital 08/12 feeling well.  Later that evening had acute onset chest pain.  ER visit included labs.  CXR, E/G, Echo and VQ scan all (-).  Seen in output setting 08/20/2003.  Felt he had pleunsy related to procedure, not related to vaccine.
This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated orally, with ROTATEQ (strength, dose, dose number and lot # not reported), which was improperly stored. The temperature excursion for Oral, ROTATEQ was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Back pain; She has got the bump also after the needle; Bump also after the needle. It was burning; Abscess; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation, reaction(s): "The last time I got the Pfizer or I got an abscess and I had to go to the hospital", "Back pain happened with the previous shots as well ". The following information was reported: BACK PAIN (non-serious), outcome "unknown"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "She has got the bump also after the needle"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Bump also after the needle. It was burning"; ABSCESS (non-serious), outcome "unknown". The events "back pain", "she has got the bump also after the needle", "bump also after the needle. it was burning" and "abscess" required physician office visit.   Aditional information: Patient started having back pain, she went to the hospital. It happened with the previous shots as well and now she has got the bump also after the needle. It was burning, she complained to the administrator, but she did not put any bandage and now she was suffering. Caller later added during interaction She thought it was an abscess because the last time she got the Comirnaty, or she got an abscess and she had to go to the hospital. And they said it was not ready yet, they told to keep putting compresses on it and it will ooze out. Then finally it did and then it closed and there was like a little something in there. And she went to the dermatologist he said she have to cut it up to get the rest of it out and she did not want to do that. So, this time the same thing happened, and it just hurts. It was not coming to a head like the other one did. She just noticed it and thought that she will be going to put hot compresses. It hurts on pressing. If she was sitting on her bed with her back against the pillow it hurts.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202300062452 same patient/drug, different dose/events;
VACCINE LEFT AT ROOM TEMPERATURE MORE THAN 2 HOURS; POTENTIALLY EXPIRED DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine left at room temperature more than 2 hours, and potentially expired drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine left at room temperature more than 2 hours and potentially expired drug administered was not reported. This report was non-serious.
Face and chest flushed for about 12 hours. Heartbeat elevated about 10+ per minute
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient received the Pfizer monovalent vaccine, but was meant and expecting the Pfizer bivalent vaccine. Pfizer drug safety report reference number.
This spontaneous report was received from a medical assistant referring to a 04-week patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 08-NOV-2021, the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot, T040208 and expiration date reported as 19-JUL-2022), dose 2.0 ml as prophylaxis was administered to the patient of 4 weeks of age (Product administered to patient of inappropriate age). No additional information was provided. No additional adverse event reported.