chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her left arm still bothered her from her first COVID-19 Vaccine dose; she also had swelling in the top of her left hand that started about a day after getting the COVID-19 Vaccine. She said her left hand little finger & the finger next to it were a little swollen too; left arm pain; This is a spontaneous report from a contactable consumer(patient). This 73-year-old female patient received 1st dose of BNT162B2 (lot#: EN6208) Intramuscular on 10Mar2021 approximately 10:00 at single dose on left arm for COVID-19 immunization. Patient history was Stroke from 2017. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Reported she had received both COVID-19 Vaccine doses. She clarified her left arm still bothered her from her first COVID-19 Vaccine dose (11Mar2021). She said she was told she should report any adverse reaction. She clarified her left arm was still sore right above and below her left elbow. She said if she bent her left elbow, or put pressure on her left arm she felt a dull left arm pain. She said she felt the left arm pain if she turned the steering wheel on her car real hard, or if she tried to lift something, like a bottle of Clorox. She said when she bent her left arm or lifted something with her left arm, the left arm pain aggravated her. she also had swelling in the top of her left hand that started about a day after getting the COVID-19 Vaccine in her left arm. She said her left hand little finger & the finger next to it were a little swollen too. She said she had to remove her wedding ring because of the swelling in her left fingers. Treatment: Reported she put ice packs on her left arm. Reported the left arm pain was still there, but the left arm pain was not as bad as it was in the beginning. Reported she called her doctor a couple weeks after she received her first COVID-19 Vaccine in her left arm. She said her doctor told her that arm pain was normal after getting a vaccine, and the arm pain would go away eventually. She said her doctor didn't evaluate her left arm. She said her left arm pain had gotten a little better. She said she still had lingering left arm pain, and the left arm pain had not gone away. Reported she received her second COVID-19 Vaccine in her right arm on 31Mar2021, providing Pfizer first: ER8737. She mentioned to the person administering the COVID-19 Vaccine that she still had pain in her left arm from the first COVID-19 Vaccine. She said the person at the COVID-19 Vaccination facility told her she should report her left arm pain. She had a stroke on her left side and didn't know if her past stroke was contributing to her left arm pain. She said she did all her therapy, and she will always have a weakness in her left arm. She said her left arm was not as strong as her right arm, since she had the stroke. She said her left arm was not painful until her first COVID-19 Vaccine was given in it on 10Mar2021. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
About 12 hours after injection, lower GI pain (8/10) followed by extreme diarrhea (9/10)  for about an hour. During the diarrhea episode: chills, profuse sweating, feeling very hot. After the episode, lower GI pain ceased, took shower, went back to  bed. In morning, feeling slightly tired, a bit low energy but otherwise OK. Definitely NOT food poisoning?friend had identical meal (steel head trout, broccoli) with no adverse effects. NOTE: Called CDC this morning to see if the above symptoms were known side effects. Agent could only find generalized circulars on Shingrix. Did my own research online and found both Shingrix product monograph (Rev. 10/25/2021) and Package Insert (2021).  Insert on page 6 lists diarrhea  and GI pain for 14% > 70 years old. WHY DIDN'T CDC HAVE THIS INFO EASILY AVAILABLE? I only wanted to varify that my side-effect were known.
Fever, body aches, shakes, body sweats, sore arm at the injection site
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of ROTATEQ lot # L000568 expiration date 10-JUL-2016 (oral as default, indication and dose number were not reported), and lot # L008053 expiration date 30-NOV-2016 were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested.
Bruise at injection site; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received first dose of bnt162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EM9810), via an unspecified route of administration on 06Feb2021(at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included sinus pain from an unknown date and unknown if ongoing Verbatim: sinus problems , allergy to plants from an unknown date and unknown if ongoing , allergy to plants from an unknown date and unknown if ongoing. Concomitant medication(s) included cefdinir taken for sinusitis from 02Feb2021 to 16Feb2021; montelukast sodium taken for an unspecified indication from 02Feb2021 to an unspecified stop date; mupirocin taken for sinusitis from 02Feb2021 to an unspecified stop date. On 06Feb2021, the patient experienced Bruises at injection site. The first dose of the Covid-19 vaccine on 06 Feb 2021. She still has bruising at the injection site. She read that it could last for 3-4 days. This has been way over that time. It is not as pronounced as what it was. She was also on an antibiotic to rule out a staph infection. She is allergic to pine trees. When providing product details, caller states she was prescribed an ointment to use for 7 days. She used it for 10-12 days. rovides Lot: 19201551, Expiry Mar2022.When she was smaller, she had a bad reaction to a diphtheria injection. She was in the 5th grade. She does not have the exact name, NDC, Lot or Expiry. She had to get a second shot to counteract it. Her body is very sensitive to certain drugs like pain medications. She is unable to provide names, NDC, Lot or Expiry. She is also allergic to raspberries. She asked if the vaccine had raspberries. She saw on the news that the second dose of the Pfizer vaccine may not be needed because the first dose is 90% effective. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Pt was given the vaccine on 3/2/00. On 3/3/00 there was erythema with swelling to injection site. Pt states on 3/3/00 there was swelling to the area that increased over the weekend. Pt also experienced a fever and headache. Pt was seen by an MD. The MD states pt had extensive erythema of the left deltoid area extending down the arm towards the elbow. The area is fairly indurated with hot brawny erythema. Examination shows no gross tenderness, it just feels tight.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or approximately 04-SEP-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 08-SEP-2016, the patient was treated by a physician for shingles, and was prescribed acyclovir for management of his symptoms. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
patient received only one dose of shingrix on 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received only one dose of shingrix on 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
numb upper arm for one week; joint pain so badly i could barely move; she could barely move; This is a spontaneous report from a contactable consumer (Patient).   A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 08:00. as dose 1, single for covid-19 immunisation. Medical history included Trigeminal neuralgua, bipolar, high cholesterol, allergies, type 2 diabetes. Patient had Allergies Dilantin, PEG, aulfa, demherol. Concomitant medications included tizanidine hydrochloride (ZANAFLEX), pregabalin (LYRICA), hydrocodone (HYDROCODONE), rosuvastatin calcium (CRESTOR), TRAZODONE. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient previously took dilantin (phenytoin) and experienced drug hypersensitivity, demerol and experienced drug hypersensitivi-ty, polyethylene glycol (macrogol) and experienced drug hypersensitivity. On 05Mar2021, the patient experienced numb upper arm for one week and joint pain so badly she could barely move. Patient received 2nd dose on 26March2021 at 8AM, in left arm. The patient recovered from the event of numb upper arm for one week. The outcome of the rest of the event was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Initial report was received 17 October 2012 from a health care professional. An unidentified patient (age, gender and date of birth not reported) with no concurrent illness, had received an intramuscular injection of FLUZONE, lot number UH719AC on 17 October 2012 and 2-3 minutes after vaccination, had developed symptoms of an anaphylactic reaction. The patient experienced urticaria, erythema, dizziness, throat swelling and shortness of breath. BENADRYL and Solumedrol were administered while at the doctor's office and symptoms began to resolve. All symptoms had subsided within 15 minutes. The patient had a history of allergies to PCN (penicillin), gentamycin and cephalosporins. Relevant diagnostic tests and laboratory data was reported as "none". Outcome was recovered. Documents held by sender: None.
Systemic: Patient passed away-Severe, Additional Details: Patient passed away on 3/9/2021
Overall, it went really well during the first day (4/10/2021), as I took a 15 mile bike ride a few hours after my shot.  On the 2nd day, I experienced fatigue, neck/muscle pain, and my wife encouraged me to take my temperature and I found I had a slight fever of 100.2F.  On the 3rd day (4/12), I felt only slightly fatigued with some neck pain but no fever at all.  Today (4/13), I have only neck/muscle stiffness (no soreness/pain) and no fatigue. I still have soreness at the injection site, but consider it mild. I don't have my 2nd dose scheduled yet, but anticipate it to be around May 6th.
Patient got vaccine 10:30 am and by 10:30 pm patient developed what she called covid arm. There was a bump the size of a walnut. Shortly after hands went numb and extreme crushing bone pain was seen. Chest pains were also seen which knocked the wind out of her. 3 days after the shot bump is the size of an orange.
Pt was seen with his twin brother for 15 month WCC and was accidently given 2 doses of Prevnar and 1 dose of Dtap
Tinnitus, dizzyness, confusion, eye pain, pressure in ears.  Started 8 days after vaccination.  Has been continuing for the past 4 days
chief complaint of a mental fog, feeling off, and SOB. Intra-uterine pregnancy at 35w2d due 4/21/2022
This case was reported by a other health professional via call center representative and described the occurrence of blurred vision in a adult patient who received FLUARIX QUADRVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In September 2015, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced blurred vision. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the blurred vision and product complaint were unknown. The reporter considered the blurred vision to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a pharmacy buyer. The patient was one of the five employees of the hospital who were administered FLUARIX QIV by the clinic. The exact date of vaccination was unknown, it could be 15th September 2015 (Tuesday) or after that. The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. The reporter also provided contact details of a nurse for more information. At the time of reporting, any further details were not known by the reporter. This case has been linked to other cases, reported by the same reporter (see cases US2015133740, US2015133746, US2015133760 and US2015133738).
PATIENT COVID POSITIVE 6/13/2022 AT REHAB. ADMITTED TO MEDICAL CENTER ON 6/14/2022 WITH ACUTE RESPIRATORY FAILURE SECONDARY TO COVID-19. PATIENT EXPIRED ON 6/29/2022.
stomach upset; arm and hands shaking; tenderness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), TREMOR (arm and hands shaking) and VACCINATION SITE PAIN (tenderness in injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement (had heart attack and had two stents). Concomitant products included DILTIAZEM HYDROCHLORIDE (CARTIA XT), PANTOPRAZOLE, HCTZ, SUCRALFATE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness in injection site). On 26-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset) and TREMOR (arm and hands shaking). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), TREMOR (arm and hands shaking) and VACCINATION SITE PAIN (tenderness in injection site) outcome was unknown.            Treatment medications include IV infusions with Reglan and Zofran for an unknown indication. Action taken with mRNA-1273 in response to the event was not applicable.
100 degree fever, persistent vomiting, chills, aches, loss of appetite, weakness, fatigue, unusual and heavy vaginal bleeding
Site itched, hot, red, & swollen; lasted 4 days; no prior vax;
throat was closing; tongue was swelling; had hives on my chest; This is a spontaneous report from a contactable consumer. This 63-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK4176) via an unspecified route of administration into the left arm on 19Jan2021 10:00 AM (at the age of 63-year-old) as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Covid prior vaccination nor tested post vaccination. No other vaccine in four weeks. No known allergies. On 19Jan2021, the patient reported that ten minutes after vaccination, her throat was closing and her tongue was swelling. Also, she had hives on her chest. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and treatment was received with Epipen, Benadryl, Deltadone and Pepcid. The Outcome was resolved for all the events on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Presented with +Covid PTA; body aches/SOB; N/V; diarrhea x 6 days; admitted with Covid PNA; tx with Vit C, ancef, rocephin, steroids, merrem, remdesivir, velteri, vanc, zinc; intubated on 8/31 continued to need high PEEP and FiO2 and discussion of prognosis with her husband led to DNR status. She became asystolic on 9/18/21 and time of death was 03:40pm on 9/18/2021.
Patient fainted within one minute of receiving the injection.  Patient was sitting down and I held the patient so they did NOT hit their head or fall in any way.  Patient awoke within a minute of fainting and felt nauseous but did NOT throw up.  Had the patient lay down for ~15 minutes and gave them a sports drink.  Patient felt normal within 15 minutes and left after 25 minutes with no further complications.  Patient did state they had not had anything to eat for several hours.
Rash formed on body; This is a spontaneous report from a contactable healthcare professional (patient's parent) via a Pfizer sales representative. A 4-month-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in Aug2019 as single dose for immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unspecified date for immunization. The 4-month-old patient received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) two months ago (Aug2019) and rash formed on body. The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
cried w/o being able to be comforted for 48hr, slept only for 15-20min;cap naps between crying, fever 100-101ax, vomiting formula, had congestion & a little cough, seen in ER 2nd day according to mom;crying non stop 2 days;only ate 8oz
59 yo M who arrives to the emergency department today with son in the setting of fall ground level sustained yesterday. States he was having some increased head aches and jaw pain bilat and wanted to be checked out. States he does not recollect the fall but was found by neighbors a few seconds later.
The next morning I felt feverish. lethargic, cranky, more so that usual. wanted to lay around and sleep for approximately 24 hours
Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 004C21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Stent placed five years ago). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LOSARTAN, ATORVASTATIN and ISOSORBIDE MONONITRATE for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-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.            No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-123403 (Patient Link).
Patient began to sweat, complained of blurred vision, and turned very pale in the face. We called 911 and I stayed with the patient monitoring heart rate and symptoms. Patient was slightly tachycardic upon initial assessment. Once EMS arrived, patient had had resolution of blurred vision and the sweating. Her vitals were normal. Her mom refused further treatment to the hospital. I recommended to follow up with pediatrician.
After injection client walked to front desk where he started sweating, became disoriented, and fainted. Client was out for about 1 min. Client sat for about 15 min with staff monitoring condition and was able to return to normal activity after about 20 mins.
Patient reported "tingling" sensation, bilateral upper extremities after second dose of Pfizer COVID-19 vaccination. Sensation radiated to neck area. Also, reports "tingling" in toes. No there other symptoms. She did have this reaction with the first dose, subsided in within 2 hours. Patient was discharged to home in stable condition.
Itching all over, Arms, legs, feet and hands with no Rash. Swelling of Hand and Feet. Started 12/29 and progressively worsened over the evening.
Patient developed a hoarse cough and elevated pink/red rash on trunk of body. The incident was reported to physician and family was instructed to give Benadryl. On 2/2/01 the rash was reported to be gone. Patient's mother felt this was a reaction to Varivax because the patient developed a rash on left thigh
Received 2-25-2004 first Hep B in left arm. Gradually resolved over 2 weeks.
Patient reported fever for 2 days after getting the vaccines, and also he has had diarrhea, swollen and painful: eyes, tongue, mouth, checks, lips. He has tried tylenol. He is still having symptoms 5 days after vaccine. I suggested benadryl and that he should see a doctor.
Approximately 5 minutes after injection, patient started feeling faint. Pallor skin color, skin was moist. Patient then proceeded to faint, followed by a 15 second seizure. Once patient became alert, a second fainting spell occurred.
Patient complained of pain in upper arm on left side of left arm and back of shoulder.  He said he has trouble moving it around easily.