chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Arm. Started about 5 hours after injection.; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medication within two weeks prior to the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced sore arm started about 5 hours after injection. The clinical outcome of the sore arm started about 5 hours after injection was not recovered.  Amendment: This follow up is being submitted to amend previously reported information: State leave blank for reporter and patient since no state provided in source. Final sentence updated to No follow-up attempts are possible.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
CL received second dose of Pfizer COVID vaccine on 318/2021 (first dose 2/25/2021). On 8/6/2021 had cough, fever, fatigue, body aches, sore throat and diarrhea. Tested positive for COVID. Patient received monoclonal antibody on 8/6/2021
Information has been received from a registered nurse concerning a 35-year-old female with a latex allergy, and allergies to vancomycin and Varivax (WAES # 0601USA02315) who on 06-JAN-2006 was vaccinated with a dose of Recombivax HB (Lot # 651852/0304R). Concomitant therapy that day included a dose of MMR II. Subsequently the patient returned to the office with hives to her neck and face, flushed face, and shortness of breath. Her vital signs including blood pressure were stable after observation at the office for 45 minutes. Her symptoms resolved without any medication and she returned home. The patient was directed to call the office if any other problems occur. No further information was available. There was no product quality complaint. Follow up information indicated that after vaccination the patient left the clinic. She then returned that day, 06-JAN-2006, with her mother with complaints of a flushed face, hives, and shortness of breath. Her vitals were stable. The patient was offered epinephrine, however the mother declined, stating that she would take her daughter home and give her medicine. No additional information is expected.
left arm pain; couldn't raise my left arm; 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), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "left arm pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "couldn't raise my left arm". Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient (Age: 68; Unit: Unknown) has tried, ice, paracetamol (TYLENOL), naproxen (ALEVE), laying on ice pack, and heating pad. She stated "The pain is going down my arm, and I don't know if I'm having a stroke or what. At first, I couldn't raise my left arm. I used the rubber band to try to strengthen it, still doing it. I'm a healthy person. I take only levothyroxine." Patient was asking for treatment advice for her arm pain.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with 3 doses of improperly stored ROTATEQ (unknown dose and strength; route defaulted to oral). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
15MAR97 started itching, & rash devel;18MAR97 LA has whelped rash around inj site;LL sl redness @ site;rash on hands, arms, palms  of hand;
within five minutes of administration, my throat became itchy, then began to close immediately. My throat became really tight and I became to feel the same in my chest. I began feeling slightly faint. Breathing became more difficult and it felt like my lungs would not expand. By this point I felt extremely light headed and needed to sit down. Health seemed to return back to normal within 30 minutes.
3/7/21 had slight headache and upset stomach which lasted the day.  Around 3/15/21 I had gastrointestinal discomfort and diarrhea which comes and goes. Today is 3/30/21 and I still am experiencing intermittent upset stomach, but the diarrhea seems to have subsided.
Severe pain in left arm and itching started about 6 hrs after the vaccine, by 16 hrs after the vaccine, eyes were swollen shut, some sob, difficulty swallowing , fever along with rash on face and neck. started taking high doses of benadryl (already had epipens on hand from insect allergy). took benadryl q 2 hrs until throat swelling went down, and some edema left face. approximately 4 hrs. started taking benadryl q 4 hours routinely x 48 hrs thereafter, took lasix qd x 3 days to help reduce the swelling,  then benadryl q hs x 7 more days
tired; itchy; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age 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 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced after first 1st dose got tired and was itchy. Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Patient received Pfizer COVID vaccine on 3/11/21 and 4/14/21. On 1/28/22, patient admitted to our inpatient facility with COVID-19 pneumonia and hemoptysis (possible Mallory-Weiss tear). As of today (2/1/22), patient is still admitted in our med/surg unit.
Arm was sore and red next day, better next day, on Fifth day started sneezing, runny nose, coughing,  next day chills and nausea. Took Covid test and registered positive for Covid
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Elevated liver, reaver, vertigo, nausea, loss appetite. No symptoms reliefs and physician suggested gallbladder removal. No relief after surgery.
Pt had a large erythematous region on her left arm at the injection site. Pharmacy sent pt to physician's office. Patient received a common antibiotic and is being monitored.
At 2:26pm, client complained of blurred vision and buzzing in ears.  Skin color pale.   2 nurses present with client. Client assisted to lie down.  BP 100/68 - P 80 - R 18.  Skin color improved.  At 2:28pm, client's blood pressure 112/56.  Client stable.  Client and client's mom requested EMS.  At 2:30pm, EMS arrived, assessed client.  Client remained stable.  Client and mom refused transport to hospital for further evaluation.
No adverse reaction - patient was given DTap instead of TDap. DTap age range is through 6 years old so patient is technically outside of the age range. No other adverse reactions to immunization.
This case was reported by a healthcare professional via a sales representative and described the occurrence of walking difficulty in a 11-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Sanofi Pasteur MSD; unknown given on 23 July 2012; varicella virus vaccine (non-gsk); Merck; unknown given on 23 July 2012. There were no concurrent medications. There were no reactions, up to date on vaccinations. On 23 July 2012 in early PM, the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right deltoid). On 25 July 2012 at approximately 10:00, two days after vaccination with BOOSTRIX, the subject experienced walking difficulty. The reporting healthcare professional reported that "within 48 hours" after receiving the BOOSTRIX, the subject had difficulty walking without assistance. The reporter strongly recommended to the subject's mother, who was a registered nurse, that they see a physician about the reaction because of "concern over Guillain-Barre". The subject was not hospitalized or considered to be in serious condition. The subject was seen immediately in the doctor's office and labs were drawn. The physician found one lab elevated (unknown which one), but was not concerned and was not concerned about the subject's reaction. By 30 July 2012, the subject was much improved and was getting around walking fine. There was no other information available at the time of reporting. On 30 July 2012, the event was resolved. The vaccination course with BOOSTRIX was discontinued.
Right lower quadrant pain; back of throat tight and full and moved to tongue; fullness in ears; some itching and fullness on the right side near the back of her tongue; This is a spontaneous report from a contactable nurse (patient).   A 50 years old female patient (weight 81.65 kg and height 173 cm) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. EL1284) on 22Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were none. It was reported that she had no allergies to anything. On 22Dec2020, the patient experienced a sharp pain in her lower right quadrant of her abdomen, then her ears started getting full, then the back of her throat started getting tight and full and moved to her tongue. It was also reported that she started feeling some itching and fullness on the right side near the back of her tongue. Her airway was intact. Nurse clarified that her reaction last night after the vaccination all happened within 12 minutes of receiving the shot. She went to the emergency room for observation and was treated with epi and Benedryl. She went home after a couple of hours. Clinical outcome of the events was recovering at time of this report. The adverse event, right lower quadrant pain, was assessed as serious (medically significant).; Sender's Comments: By close temporal relationship ('within 12 minutes of receiving the shot') and absence of factors which may provide an alternative cause, the company cannot exclude a contributory role of the BNT162B2 administration in the development of the serious event reported as 'sharp pain in her lower right quadrant of her abdomen'.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
A serious spontaneous report of passed out, increased heart rate, shaking, feeling tired, lethargy, headache, feels cold, chills, and nausea has been received from a consumer concerning a 17-year-old female subsequent to FLUMIST. Neither past medical history nor concomitant medications have been reported. The patient received FLUMIST on 31-Oct-2008. One week after receiving FLUMIST, the patient started feeling tired and having headaches. On 09-NOV-2008, the patient passed out while at work and paramedics transported her to the hospital. She had symptoms of increased heart rate and lethargy. While at the ER, all tests were normal and the patient was released. The following week, the patient still felt tired, reported feeling cold, had chills with shaking and nausea. The patient was taken back to the physician on 20-Nov-2008 who indicated that the patient could be experiencing stress and gave her something for her stomach. The outcome was not reported.
This spontaneous report as received from a pharmacist via agency refers to a 65 year old female patient. On 19-SEP-2014, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (expiration date August 2014) for immunization for prevention of pneumonia (dose, route and strength not reported). The patient's relevant medical history, relevant concomitant medications and relevant past drug history were unknown to the reporter. There was no relevant lab data. The patient did not report any problems after receiving PNEUMOVAX 23. As of 20-SEP-2014, it was unknown if the patient was still on PNEUMOVAX 23 and the outcome of receiving PNEUMOVAX 23 was unknown. The lot number was unknown to this pharmacist. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA I started developing  itchy hives and rash on tops of my hands and around my elbows.  Also on my feet and under my armpit.  There are also random hives appearing on different parts of my body.  These symptoms have been happening during daytime hours on 3 separate days so far, starting two days after my second dose of the Pfizer vaccine.  After taking a cetirizine tablet the rash and hives subside after a couple hours.  Then it starts up again in the morning upon arrival at work.
01/5/2022 Tested positive for COVID. I received my booster shot I went home and I was sore on the arm, I woke at at midnight and was nauseous. In the morning I was having chest pain and in my back around my shoulder blade it was an extreme pain. I got in contact with my PCP's nurse. I was told to rest and monitor myself throughout the weekend. I had extreme fatigue, and by the Wednesday of the following week I was diagnosed with a sinus and ear infection. I am taking antibiotics and a nasal spray. I am at times experiencing shortness of breath. Every since I have gotten sick, I have not been able to be active as I was before.
experience the cramping in his arms; experience the cramping in his calves; cramps woke him up at least five times; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times). At the time of the report, MUSCLE SPASMS (experience the cramping in his arms), MUSCLE SPASMS (experience the cramping in his calves) and MUSCLE SPASMS (cramps woke him up at least five times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
I started to feel body aches around 11 PM and they woke me up from my sleep. From there my symptoms got more severe to the point that I could not get comfortable laying in bed. I also got a headache, insomnia, chills, and soreness at the injection site. All of the symptoms lasted about three days, but they were most severe especially the chills For the first 24 hours.  Because I did not want to lessen the efficacy I tried not to take any Tylenol for at least the first 24 hours to relieve the symptoms. Instead I eat a marijuana gummy to alleviate the pain.
chest tightness; generalized weakness; palpitations; body aches; This case was reported by a physician via call center representative and described the occurrence of chest tightness in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   The patient's past medical history included neck pain, shoulder pain and pain in arm.   On 21st August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, 1 days after receiving Shingrix, the patient experienced general body pain. On 23rd August 2019, the patient experienced palpitation. On 27th August 2019, the patient experienced weakness generalized. On 3rd September 2019, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness, palpitation, weakness generalized and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chest tightness, palpitation, weakness generalized and general body pain to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that patient received Shingrix and experienced had body aches. On 23rd August 2019, 2 days after vaccination the patient experienced palpitations. On 27th August 2019, 6 days after vaccination, the patient experienced generalized weakness and on 3rd September 2019, 13 days after vaccination the patient experienced chest tightness. None of these symptoms have resolved at the time of reporting. The reporter had consented to follow up.
7:30 pm the same night, hive bilateral upper arms - responded to BENADRYL, but next am hives again present.
Information has been received from a physician concerning a 73 year old female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) approximately on 23-JAN-2009 (3 to 4 weeks ago).  The physician stated in approximately January 2009 a patient experienced a more intense than usual and longer duration of an episode of Herpes Simplex 2 weeks after administration of the vaccine.  The patient also experienced a change in her rhythm.  The physician did not know if the administration of ZOSTAVAX (Oka/Merck) was related to her patient's symptoms.  As of 23-FEB-2009 the patient was not recovered.  The patient sought unspecified medical attention via telephone.  Additional information is not expected.
chills; runny nose; bones kind of ached; tiredness; headache; muscle pain; joint pain; feeling unwell; swollen lymph nodes in my neck; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: was not reported), via an unspecified route of administration on 04Mar2021 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Mar2021, the patient experienced chills, runny nose, bones kind of ached, tiredness, headache, muscle pain, joint pain, feeling unwell, and swollen lymph nodes in my neck. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Had varicella vaccine 5/29/98/ Lot # 1568E. Pt developed typical vesicular erythematous lesions of varicella; more than 200 lesions all over.
Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of skin.  Administered Zyrtec and resolved within 20 minutes.
Delayed menstrual cycle. Prior I was clockwork - literally. I calendar and would start precisely when  expected. The last two months have been very late.
blinding headache; blinding headache; nausea; dizziness; This is a spontaneous report from contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. On 30Jan2021 at 09:00, the patient experienced blinding headache, nausea, and dizziness. The outcome of the events was unknown.  Information about Lot/Batch has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
child devel hives, itching skin & runny nose on the back, side, & abd;child given DPH & parent called MD;MD related hives caused by vaccine;
Very swollen and painful lymph nodes and tissue under arm.  Very uncomfortable and I am now at day 8 and it is not fully recovered.
Covid vaccine: Pt reported she received first dose of Moderna vaccine at approximately 2:30 pm. Remained at site for observation for 15 minutes. About 30 minutes after receiving vaccine says her throat started to feel as if was narrowing, so she returned to observation site for evaluation. Describes known history of allergy to dairy (?hives) and mild reaction to shellfish. Denies history of anaphylaxis.  Has never needed medication for allergic reaction. Otherwise healthy.  Exam was positive for pallor, periorbital edema, swelling of lips, tongue, uvula, and changing quality of voice, as well as tonsillar and pharyngeal swelling, thready pulse. Given concern for anaphylaxis, administered epinephrine in R anterolateral thigh. 911 called.On reexamination, oropharyngeal swelling slightly improved, voice normalizing.  Gave handoff to EMS.   Patient was transported by EMS to emergency dept.
Client presented for second dose Moderna. Unable to depress plunger and vaccine leaked out all of his arm. Estimated only 0.1 ml administered into left arm.  Client consented to revaccination in right arm.  No issues.  Syringe was supply: 1 ml vanish point syringe Lot #2025-06-28.
Started to have congestion, sore throat, chills and a fever. Took a Home COVID-19 test and was positive. Called doctor and was prescribed Paxlovid, most of my symptoms had left except I was extremely fatigued for 2 weeks afterward. Tested negative for COVID-19 a full month later. Then I was exposed to a friend who has COVID-19, and I tested positive a week later. Contacted doctor again and was prescribed Paxlovid again.