chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exactly 10 hours after my shot both legs from my thigh to my toes I had severe cramps and cannot move I couldn?t sit I couldn?t bend my legs to mute go up the steps at lasted for an hour broke out in sweats heart was racing finally subsided after an hour then all night I got little cramps on my toes or my calves
Information has been received on 18-JUL-2016 from a physician via a company representative referring to a male patient of unknown age. The physician reported "about 6 months ago" the patient was vaccinated with the first dose of GARDASIL 9. A few seconds after the first dose of vaccine the patient experienced two episodes of syncope, one right after the other. The patient fully recovered while still in the office. The causality of two episodes of syncope was not reported. No further information was reported. Additional information habeen requested.
Fever highest 103F, head ache, body ache, chills, tired, unable to eat symptoms lasted 3 days and during that time my heart went back into atrial fibrillation
Left deltoid blister after 24-48 hr of shot  which turned dark black 3-4 minutes slightly different site laterally of shot - when bandaid was pulled off. Also c/o left arm pain- numbness weakness slight after shot 24-48 which subsided when came to here on 5/22/07. Also history of reddish rash around vaccine site date not witnessed on 5/22/07.
Fever of 101.5 (I usually run 97.3 degrees), chills, all-over body aches, headache. Symptoms lasted 36 hours, took aspirin for fever and aches, Coke to settle nausea. My temperature this morning was normal at 96.9 and headache, body aches and chills have resolved.
This is one case out of a cumulative total of 233 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 August 2014. These 233 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 28 August 2014 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3607AA received on 26 May 2010, dose two lot number C3607AA received on 28 July 2010 and dose three lot number C3669AA received on 18 September 2010 and dose four of PENTACEL, lot number C4059AA on 07 October 2011 (routes and sites of administration for all doses were not reported). The subject developed a cough on 04 July 2014, approximately 32 months after the last dose. On 15 July 2014, the subject developed a paroxysmal cough. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 July 2014 for five days. The subject was not hospitalized. At the time of final contact on 22 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 49 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
On 09/25/2001 shot given. No feelings of being "not well". Two days following vaccine noticed 3-4 cm lump beneath left ear; glandular area. Non-tender to touch. No fever noted. Remains swollen at this time. to check in with Clinic for evaluation.
At approximately 3:15 pm on  March 6, 2021  I was sitting on the couch and all of a sudden felt like something happened in my head and I was going cross eyed and double vision/impaired vision and thought I was going to black out, but after a minute started to get better. After which i felt i had to be very careful walking around like something was going to happen again in my head.. and I felt like i was groggy or in the fog for about 3 or 4 hours following the incident.  I was sure I had experienced a TIA because I never had anything like that happen in my life.
Information has been received from a physician and the office manager concerning a 9 week old male patient who on 03-APR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reaction or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Rash on the right arm - forearm and elbow, red, raised, itchy with little postules
This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 64-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). On 19th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 30th September 2015, 11 days after receiving BOOSTRIX, the patient experienced local swelling and irritative cough. On an unknown date, the outcome of the local swelling and irritative cough were not recovered/resolved. It was unknown if the reporter considered the local swelling and irritative cough to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient experienced red bumps on both legs and also she experienced a cough and tickling in her throat. The patient followed up with her doctor and was referred to her pharmacy where she received the vaccine.
Pt got pale & dizzy, BP dec 70/50 from 116/74; Asked to lay flat given 02 by mask; Better in few minutes; States gets faint everytime gets shot & had no breakfast;
Muscle weakness, twitching in left pinky finger, fever, fatigue, loss of appetite, general overall not feeling well. Still experiencing symptoms after 7 days with no relief.
blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; horrible reflux; severe pain in her diaphragm; felt like there was a lump in her throat; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 03Apr2021 01:45 (Batch/Lot Number: ER8733) at the age of 61 years old as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergy. Concomitant medication(s) included Vitamin C [ascorbic acid] and Calcium;Vitamin D (nos) supplements; both taken for unspecified indications, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6205), administered in left arm on 13Mar2021 12:00. On 04Apr2021 09:30 (also reported as approximately 20 hours after the vaccination), the patient experienced blisters on her lip, mouth and back of throat. Also on 04Apr2021 09:30 (also reported as about 24 hours after that), horrible reflux with severe pain in her diaphragm and felt like there was a lump in her throat with difficulty swallowing. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included diphenhydramine (BENADRYL), methylprednisolone (MEDROL Dose Pack) and famotidine (PEPCID). Outcome of events were recovering.  Follow-up attempts are completed. No further information is expected.
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
pt tested positive for COVID as an outpatient and after receiving monoclonal antibodies he developed worsening s/s and was admitted to the hospital
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 or lot # reported as L03966, expiration date 04-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Lot number [L03966] is an invalid lot number for hepatitis b vaccine (recombinant). Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351: US-009507513-1611USA013515.
After the shot in April starting to have severe back issues. Started by seeing my long time chiropractor and we treated it as a pinched nerve issue,  The pain radiated down the opposite side then the right side I am used to (left side) across my lower back,  down my hip to back of my knee. It has affected my walking as well as every day activity such as pulling my pants on to get dressed and putting my shoes on. This also created what I call a dead leg type issue where I was literally dragging my left leg at times. After a few chiro treatments went to family doctor. She put me on some muscle relaxers and had an xray done.  Still was not getting better 6 weeks later. Followed up with chiro has MRI done, Showed the pinched nerve on right side could not find a nerve pinched on the left. Still was having issues with lower back and leg. Went through many chiro visits as well as massage therapy treatments. I went from walking 13 plus miles comfortably to barely being able to walk one. It is now November and I still and having issues. I am still having everyday issues with bending my left leg, and it going dead leg on me, still having pain from lower back down hip to knee.
dizziness; swelling in the left cheek in the face; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, a Consumer calls for information about if she should receive the second dose of the Pfizer's COVID-19 vaccine considering that she developed side effects after the administration of the first dose. The Consumer reported that she had dizziness and swelling in the left cheek in the face. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Pt experienced high fever of 103.1, inability to sleep, screaming. Fever broke for 1 day then manifested. Pt experienced flu and cold symptoms. Fever lasted one week. MD said it was an unrelated virus. Child never ill before the vaccine. The child took longer to recover than his sister.
Information has been received from a pharmacist concerning a 75 year old female with an allergy to penicillin and sulfa drugs, and no other medical history who on 10/15/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (kit 647661/0055R). Concomitant therapy included levothyroxine NA Synthroid, escitalopram oxalate Lexapro, Loratadine Lorazepam, rabeprazole sodium Aciphex and zolpidem tartrate Ambien. On 10/15/2005 the pt developed a huge red knot at the injection site which was accompanied with lots of tenderness in the area. Unspecified medical attention was sought. No lab diag test were performed. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional information has been requested.
An MD reported that a 9 mt old female received her 2nd dose of Prevnar on 2/24/03. Ibuprofen was administered on the day of immunization. On the following morning, 2/25/03, the child experienced a "red generalized rash on her chest, abdomen, and leg." No fever or fussiness was reported. Follow-up information received 15-Apr-2003 from the physician provided patient outcome (recovered). The child recovered.
Patient's son recently was exposed and diagnosed with pertussis and the entire family had been exposed and infected.  The patient was seen at a clinic. Patient was given antibiotics and Tdap vaccination. This was done earlier in the day and during the evening the patient began having a rash over his back with small raised bumps. Patient also had swelling of his lips.  Patient was treated with intramuscular Benadryl and oral Zantac and prednisone. Patient discharged from the emergency room with prednisone, Zantac and Benadryl.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: First report failed to submit. Pt experienced a syncope event within 1-2 minutes after receiving. It took ~30 seconds for her to regain consciousness. Afterwards, she experienced significant dizziness/nausea and could not pick up her head without these symptoms instensifying. After ~30 minutes, a full bottle of water, and at least 3 BP checks (all of which read <95/60), there was no improvement in s/sx and BP was still low. Recommended pt to go to ER. Improved by next day after fluids/zofran.
Systemic pain, lethargy, and radicular symptoms into the BL lower extremities.
Chills, body ache started at approx 12:30 Tues, progressing to severe lethargy and loss of appetite, fever and headache by 5:30 pm. Majority of these symptoms were mostly relieved by sleep and taking acetaminophen.  Jan 27 symptoms reduced to headache and Injection site tenderness progressed from mild to moderate Tuesday into a raised red welt of approx 3 inch diameter which became hot to touch and increasingly tender.
Sore arm; Fever of 101; Chills; Nausea; Aches; Joint pain; Weakness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 30Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included bee sting allergy-anaphylaxis. 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 vaccination. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 30Aug2021 at 20:00, the patient experienced sore arm, fever of 101(Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore arm, fever of 101 (Unspecified units), chills, nausea, aches, joint pain, weakness and fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
21 yo G2 P0010 EDC 4/14/07 at 21 weeks gestation came for routine prenatal care 12/5/06. Pt received Td Vaccine at approximately 1pm. Felt well before and after shot. Started feeling ill about 6pm. Reported feeling feverish with upset stomach. Vomited x 3, felt dizzy, vision blurry, and fainted. Family with her and patient stated family had difficulty arousing her and called EMS, "out x 20 minutes". Taken to  hospital and kept for 12 hours. Hit her stomach and kept for fetal evaluation. Stated had fetal sonogram and EKG done there. Had 3-4 episodes of watery diarrhea in the night. Discharged home at 6 am on 12/6/06. Now feeling tired and weak. No fever now. Injection site sore and swollen.
Information was received from a nurse practitioner concerning a 22 year old with a needle phobia and admitted to passing out with piercings and tattoos in the past who on 21-MAR-2009 was vaccinated with a second dose of GARDASIL. The patient subsequently experienced a syncopal episode. They sent her to the emergency department to be further evaluated. This event was not felt to be caused by GARDASIL but was believed to be caused by the needle as it occurred immediately as the injections was being given. The injections was administered. The patient was discharged from the Emergency Room. Additional information has been requested.
begin w/malaise w/in 24 hrs p/vax then dizziness, nausea & vomiting;
exp an anaphylactoid-type react following vax w/Engerix-B;
This spontaneous report was received from a registered nurse and refers to a 10 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 119 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
nasal congestion; Slight fever 99-101; Brain fog disability; Cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 73 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cataracts", start date: 2021, stop date: Feb2022; "Cataract surgery", start date: Feb2022 (unspecified if ongoing), notes: Cataracts removed, intraocular monofocal lens. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 12Oct2021 as dose number unknown, single. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 14Oct2021, outcome "recovered" (21Oct2021), described as "Cold symptoms"; FEELING ABNORMAL (disability) with onset Nov2021, outcome "recovering", described as "Brain fog disability"; NASAL CONGESTION (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever 99-101". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99?-101?; Ophthalmological examination: (03Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye; (10Feb2022) successful surgeries, notes: Monofocal lenses inserted in both eye. Therapeutic measures were not taken as a result of feeling abnormal.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EJ1686), in left arm, as dose 2, single (Batch/Lot number: unknown), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9484) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mango allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "osteoarthritis of the spine" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "depression" (unspecified if ongoing); "cervical stenosis" (unspecified if ongoing); "Meralgia paraesthetica" (unspecified if ongoing); "bilateral hip replacements" (unspecified if ongoing); "cervical ACDF" (unspecified if ongoing); "Thoracic outlet syndrome" (unspecified if ongoing); "leg weakness" (unspecified if ongoing); "migraines" (unspecified if ongoing); "vertigo" (unspecified if ongoing); "back pain" (unspecified if ongoing); "muscle spasms" (unspecified if ongoing); "CRPS of hand" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM, start date: 14Dec2020, stop date: 13Jun2022; PREGABALIN, start date: 14Dec2020; TRAZODONE, start date: 30Nov2018; CYCLOBENZAPRINE, start date: 31Dec2018; ALBUTEROL [SALBUTAMOL], start date: 31Dec2015. Past drug history included: Metaxalone for Drug allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative; Positive, notes: Tested positive this morning. Have all of the COVID symptoms now. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment (Paxlovid), from 14Jun2022 to 19Jun2022. Took for five days. Tested negative. General allergies acting up. Got worse yesterday. Tested positive this morning. Have all of the COVID symptoms now. Almost feel worse than originally. Also, face was numb and immobile on one side for a day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Patient received the second booster dose. Date the vial was initially stored in the refrigerator was  Unknown. Date of administration of vaccine were noted as 2 doses 05 Apr 2022, 13 doses 06 Apr 2022, 2 doses 07 Apr 2022, 4 doses 08 Apr 2022. The vial did not undergo any temperature excursions. No treatment medication reported.
Chills, shivering, nausea, diarrhea, dizziness, tiredness. Stomach upset lasted a few hours. Chills and shivering lasted over 24 hours. Dizziness and tiredness was about 48 hours.