chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First day I was extremely fatigued, had headache and went to bed early. Next morning, the 25th, my left arm hurt at injection site, and I was unable to raise my arm up to shoulder level because of extreme muscle pain. No swelling or rash. Horrible headache, very fatigued. Took ALEVE in morning. By afternoon, I had a 102 degree fever. By evening, the injection site had swollen a lot, and had red lines and spots on it. Took 2 ALEVE again that night and iced the site. Next morning (today), the fever is gone, but I still have intense headache and the injection site is still swollen. I can raise my arm slightly higher, but not much.
Severe abdominal pain started at around midnight day of the vaccine, checked into emergency room where I was diagnosed with appendicitis and admitted. Around 10am I received an appedectomy.
Fatigue; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in the left arm on 23Feb2021 at 11:32 (Batch/Lot Number: EN5318) at 86-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included hypertension from 1981 and ongoing, ongoing High cholesterol from an unspecified date (" not sure 40 yrs. ago"). There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 02Feb2021 (first dose, right arm, intramuscularly, Lot Number: EN5318 11:30).On an unspecified date in 2021 (also reported as 08Feb2021), the patient experienced fatigue (non-serious); with no treatment received. The clinical course was reported as follows: The adverse events occurred six days after the first vaccination, which kept the patient in bed for half a day. At which time her appetite returned, and the dizziness and nausea stopped. It really did not seem significant now, because after the second dose, the patient had no reaction at all; not even a sore arm, except feeling tired (as reported). There were no relevant tests. The clinical outcome of the event was recovered on an unspecified date. The patient considered that the bnt162b2 had a causal effect to the adverse event.
Pt states onset of fever, myalgias and sore arm about 3 hours, post vax, while at work. On 2/27/01, in with complaint of sore throat, fever of 102.5F, myalgias and sore arm. No erythema. Edema at injection site. Improved on 2/28/01. Viral syndrome versus vaccine reaction.
Involuntary & uncontrollable muscle contractions.  Was only bad for several minutes, occurred several times over a few hours
"Moderna COVID-19 Vaccine EUA" 3/4/21- immediate pain in left shoulder 3/5/21- 99.6 temp; arm pain; nausea; headache; chills; sweats 3/6/21- 100.2 temp; arm pain; nausea; headache; migraine; stomach discomfort; body aches 3/7/21- 99.4 temp.; arm pain; nausea; ;headache; stomach pain; insomnia; fast heartbeat; anxiety 3/8/21- arm pain; nausea; headache; stomach pain
Information has been received from a registered nurse (R.N.) concerning a 12 year old female patient with milk allergy and no pertinent medical history reported, who on 12-MAR-2003 was vaccinated subcutaneously in the left thigh with a dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). No concomitant medication was reported. It was reported that now the patient had breakthrough chickenpox and on 21-MAR-2011 experienced an itchy rash on face, arms and chest. Also the patient had a headache off and on for one day (specific date unknown). The patient was afebrile. It was reported that the patient had exposure to children at school that had chickenpox. It was unknown if these children at school were vaccinated. The patient was instructed to stay out of school until no new lesions or the lesions had crusted over. Patient was treated with BENADRYL over the counter as needed, TYLENOL as needed, calamine or hydrocortisone as needed for itching. No labs were performed. Patient sought medical attention (office visit). At the time of reporting the patient was recovering. Follow up information has been received from a physician concerning the now 10 year old female patient with no illness at time of vaccination who on 12-MAR-2003 at 15:45 was vaccinated subcutaneously in the left anterior thigh with the first dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 at 16:00 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). It was reported that on 22-MAR-2011 the patient had varicella disease breakthrough despite 2 doses of varicella vaccine (Merck). The patient recovered on an unknown date. This is one of several reports received from the same source regarding siblings (WAES# 1105USA02388). Additional information is not expected.
Patient had COVID in mid March 2021.  After recovery of COVID, he waited for 31 days then went and get his COVID vaccine (J&J) on 4/3/2021.  Three days after the vaccine, patient developed bilateral eye redness, pain, and photophobia.  Patient waited for symptoms to improve; however, eye redness, pain, and photophobia got worse.  He started to notice blurred vision and loss of vision in the left eye.  He presented for an eye exam on 4/26/2021.  He was diagnosed with bilateral severe uveitis glaucoma.  His eye pressure was 35 in the right eye and 45 in the left eye.  Vision was 20/ 60 right eye and 20/ CF 1 ft left.  Glaucoma eye drops and steroid eye drops were started.  In follow up visits, eye pressure dropped and inflammation cleared slowly over the next two months with treatment.   He had full recovery of vision.
Information has been received from a physician concerning an 11 year old female patient with a history of occasional headaches and no known drug allergies who on 03-SEP-2009 was vaccinated intramuscularly with a 0.5ml GARDASIL (lot number not reported). There was no concomitant medication. On 03-SEP-2009, after administration of GARDASIL the patient experienced an increased in the frequency and intensity of headaches. The patient sought medical attention via office visit. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from the physician concerning the patient who on 03-SEP-2009 was vaccinated intramuscularly into the left deltoid with the first dose of GARDASIL (lot # not reported). There was no illness at the time of vaccination. On an unspecified date the patient developed persistent headache. There were no laboratory diagnostic studies performed. At the time of the report it was unknown if the patient had recovered. Additional information has been requested.
After the first vaccine on 14JAN2021, Upset stomach followed by loose projectile stools 3-4 days in a row in the late afternoon and early evening hours between 4 and 7pm. Initially thought it was due to food poisoning but spouse who also had his shot (same day) and we eat same foods, he did not have these symptoms. Finally called PCP on 20JAN2021, as the diarrhea was not subsiding; but it did finally subside a day later and back to normal stools by 22JAN2021. 12FEB2021 the second Moderna vaccine given around 1150AM; same loose projectile stools came with upset stomach around 4PM; will fill out another form. Informed PCP.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 27-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number N025428 and expiry date 27-SEP-2018, also reported as 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35 °F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA004452: US-009507513-1811USA008119: US-009507513-1811USA008123.
body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Apr2021, for Covid-19 Immunization, reaction(s): "arm pain". The following information was reported: PAIN (non-serious) with onset 30Apr2021, outcome "unknown", described as "body pain".  Additional information: The patient received his 1st dose on 08Apr2021 and he experienced arm pain. Today, he received his 2nd dose 30Apr2021, and he was currently experiencing body pain. He wanted to know if he can take a pain reliever similar to Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Experiencing intermittent left arm buzzing and tingling feeling from injection site to mid-palm area. Occurs everyday.
fever; did not feel well; 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 70-year-old female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (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 1), for Covid-19 immunization, reaction(s): "and did not give correctly"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "and did not give correctly".  The following information was reported: MALAISE (non-serious) with onset Nov2021, outcome "unknown", described as "did not feel well"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received Lymerix vaccine 1999-2000 (3 doses); developed severe neck, back and shoulder pain in Nov. 2000; received various treatments from 8 different doctors including current treatment which is physical therapy, acupuncture and medication. Annual follow up on 01/28/04: "Pt did not recover from adverse events.  Continued pain in joints."
Feb 4, 2021 - 7:35 pm - I received the Moderna Covid vaccine in my left arm.  9:00 pm - I started having bad arm pain   Feb 5, 2021 - At  about 1 am I had to leave bed to sit in a chair because it hurt too bad to lie down with my arm pain and I could not sleep. I continued to have bad arm pain all day. A cold wash cloth helped a little. I tried rubbing it, but that did not seem to help. It hurt so bad that I could not lift my arm over my head.  Feb 6, 2021 - At about 6 am, I had a bad headache which continued all morning. At about 12:30 pm it became severe. I did not want to take any pain relievers in case they would interfere with antibody development. However, my head pain became unbearable so I took two Extra strength Tylenol at 1:20 pm. (This was about 30 hours after COVID shot. I was even concerned about having a stroke or other health problem due to extreme head pain.).   By 2:00 pm I was feeling much better. The headache was gone by 6:00 pm without taking any more Tylenol. My arm pain was still there, but was a little better.  Feb 7, 2021 - My arm pain was still there, but was a little better.  It still hurt to raise my arm.  Feb 8, 2021 - I only had minor arm pain.  Feb 9, 2021 - Basically all better with just very minor arm soreness.
It was reported by the safety officer that the guest was walking up the stairs to observation after receiving the vaccine and stated to her mother that she was feeling lightheaded and sat down on the stairs. Guest appeared pale, skin was cool and clammy. EMS was called. Guest remained sitting on the stairs when EMS arrived. Vital signs were taken and were WNL. Guest was transferred to a cot and monitoring continued. Guest was talkative. About 15 minutes later she sat up and began sipping juice. Denied lightheadedness and vertigo. Vital signs remained stable. She was released by the medics.  Went home with her mother.
Felt like I had the flu; Fever/ up to 100.9/ febrile for close to 24 hours; Chills; Body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to mold (has previously been exposed to black mold). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1500 mg every eight hours. In February 2021, INFLUENZA LIKE ILLNESS (Felt like I had the flu), PYREXIA (Fever/ up to 100.9/ febrile for close to 24 hours), CHILLS (Chills) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: up to 100.9°f. (High) a fever of 100.9°F..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient is on Type 2 Diabetic medication.   This case was linked to MOD-2021-301965, MOD-2021-302003 (Patient Link).
Fever,  sweating, lightheadedness, fatigue, severe body aches, chills, sore throat, stabbing pain in various areas of my body.  Shortness of breath.  Pain with swallowing .  All of these things still present.
The vaccine has had an impact on my reproductive system. Menstrual Period was 4 days late after 1st shot.  Menstrual Period is 9 days late and counting after 2nd shot. My period has  NEVER been late unless I was pregnant.
pt recv vax & devel a swollen arm;9 other pt also had the same exp p/vax WAES96101079 and 98060219-98060226;
Nursing error, Patient received HEP B 0.5ml instead 1ml on 08/11/2022. Per provider outcome: no adverse event note. The 2nd dose of HEP B 0.5ml will not count and patient received correct does on 11/17/2022 and needs to return to clinic for another HEP B 1 ml to complete series. Pt aware.
No energy, No appetite, dizziness, low fever all symptoms since day of vaccination, except low fever started on 5th day. Sister same symptoms form also faxed.
Fever, nausea, headache, weakness 23 hours after vaccine. Bed rest, tylenol and felt better following day.
Maybe 2 wks after #2 HPV, developed neck pain that progressed to right then bil. arm and leg numbness and weakness. Hospitalized and dx with transverse myelitis. Being followed by neurologist.
Initial report received from a healthcare professional on 16 May 2013. An 11-year-old female patient, had received an intramuscular dose of ADACEL vaccine (lot number: C4332BA) in left deltoid and an intramuscular first dose of MENACTRA (lot number: U4593AB) in right deltoid, both on 14 May 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. Concomitant medications were not reported. The patient had received last DTaP dose in 2006. On 15 May 2013, one day after vaccination, the patient developed redness, warmth and swelling at both right and left deltoid. The redness on right deltoid was 6 cm and the left deltoid was 9 cm. No laboratory tests were done. On 16 May 2013, the patient was evaluated by the physician and prescribed BENADRYL and cool compresses as corrective treatments. At the time of this report, the outcome of events was unknown. Documents held by sender were none.
12/18/02 fever per father. 12/20/02 rash all over body. States clinic looked like measles. 12/23/02 clinic visit. maculopapular rash-2 days to vaccine.
remained in building p/MMR vax given; p/30 minutes noted red, swollen area @ site but no other sx; ice applied; DPH given;
Abrupt onset of wheezing, treated with albuterol and required Emergency Room visit.
Erythema, tenderness, warmth 8cm x 12cm developed 1 inch below Tdap site.
Information has been received from a Medical Assistant concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergy who on 23-DEC-2008 was vaccinated with first dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. On 23-FEB-2009 she received second dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. There was no concomitant medication. On 24-FEB-2009 the patient experienced "rash" on both of her elbows and headache. There were no Laboratory Diagnostics Studies Performed. The patient sought unspecified medical attention. Additional information has been requested.
45 minutes post vax the pt experienced numbness and tingling around the mouth, she felt as if her head were about to explode, she saw sparkly lights, had a migraine-like headache and stuffy nose, and her ears plugged up. No treatment was given. The most recent information received reports that the pt recovered.
The patient came in for a Novavax vaccine as a booster after Janssen initial vaccine.  He  refused to get an mRNA vaccine.   He was given the Janssen vaccine instead of Novavax.  He has not reported any adverse events at this time.
On 3-17-11 mom returned to clinic for additional vaccines and requested child not be given additional flu vaccine. Stated arm (L) was swollen the day following vaccines given on 2-8-11. States child had a fever up to 103 degrees orally for 2 days. Urgent care visit on 2-11-11. Mom states no treatment.
Hospitalized for sever seizure; This is a spontaneous report from a contactable consumer. This 50-year-old male consumer (patient himself) reported received first dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EW0162), dose 1 via unspecified route on an unspecified date in Apr2021 as dose 1, single and received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number EW0172), dose 2 via unspecified route on an unspecified date in May2021 as dose 2, single for COVID-19 immunization (age at time of vaccination 50 years). The patient medical history was none, and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. On 22May2021 the patient was Hospitalized for sever seizure. The patient treatment received for the adverse event such as many tests, anti-seizure medication. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Myalgia, Arthralgia, Fever, Rash, NauseaVomiting, Fatigue, Flu-like Symproms Narrative: Symptoms began evening of injection
Administered saline diluent without lyophilized component; Administered saline diluent without lyophilized component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 3-year-old male patient who received Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   On 24th September 2021, the patient received Hiberix. On 24th September 2021, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter administered 0.5ml of saline diluent without lyophilized component to the patient, which led to preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
On 4/21/21 pt received dose of moderna at a vaccine clinic. Upon further documentation it was discovered that pt had already received a dose of pfizer on 4/8/21 at a clinic. Reached out to pt who confirms that he received dose of pfizer on 4/8/21 and dose of moderna on 4/21/21. He denies any adverse side effects since receiving dose of moderna on 4/21/21
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 12-JUL-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot number N034401 and expiry date 09-MAY-2019 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9°F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA008124: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120: US-009507513-1811USA008119: US-009507513-1811USA004452.
This case was reported by a physician via a representative and described the occurrence of HEPATITIS B antibody negative in a 13-year-old subject of unspecified gender who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date the subject received 3rd dose of HEPATITIS B vaccine at 0.5 ml to complete the primary Hepatitis B series. At an unspecified time after completion of the Hepatitis B antibody negative. At the time of reporting the event was unresolved.
Red hot extremely swollen arm, chills, fatigue, tachycardia, fever 101.2F, nausea, diarrhea, headache.
Began feeling general fatigue a few hours after second dosage. Approximately 12hrs after dosage I had a fever ranging between 102-104 that lasted for 2.5days. My baseline body temperature runs 94-96. I?ve also noticed 3 separate occurrences of sleep walking after the second dosage. I?ve never had a sleep walking issue ever.