chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body pain; almost fainted; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL) and etodolac (MANUFACTURER UNKNOWN) for unknown indications taken on unknown date and unknown if still ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 29Apr2021 at 08:30 the patient woke up with body pain, went to the bathroom and when stood up from the toilet, almost fainted. The patient was given alcohol to smell and did not entirely faint. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event body pain and almost fainted was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt woke up 29NOV94 thigh swollen, small rash radiating around inject area 1"- no pain, no fever-mom notified MD; 2DEC93 area appears healthy-small area where shot given dark-poss bleed into tissue;
Extremely sore upper arm for 3 days.  Nausea begin on 3/11 in the morning. Vomiting on 3/12 in evening. Vomiting caused petechiae on around eyelids and upper cheeks, throat swelling with bright red streaks. Started Benadryl every 4 hours for 24 hour period until swelling subsided.  Liquid diet of broth, plus antacid.  3/13 Less nausea, still on liquid diet of broth, flat soda Benadryl every 4 hours.  3/14 extreme fatigue, abdominal cramping followed by solid bowel movements.  Added rice with broth to diet.
Patent was accidentally administered the wrong covid-19 vaccine. Patient received Moderna vaccine on 05/07/2021 and returned for second dose on 05/28/2021, in which pfizer vaccine was given.
On 7/28/01 pt's upper left arm became hot and swollen. She had no fever. On 7/30/01 pt was taken to the ER since her condition did not improve. She was told she had an allergic reaction. She was put on antibiotics and steroids.
Began with swelling, fever spot, and itching at injection sight.  On Sept. 9 achy joints in hip, head to toe rash,  face feels very hot, severe headache. At this point, no relief.  I am curious how long this is expected to last.
19MY98 evening fever, irritability-APAP;20MAY98 AM upon awakening c/o dizziness-parent noticed disorientation, glazed eyes, anorexia, fever (?), swollen red arm-APAP improvement noted as day went on;21MAY98 sore arm-no other problems;
RESIDENT W/O EXERTION/BREATHING DIFFICULTIES, POX 71%-72% WITH O2 AT 2L PER NC. LUNGS SOUNDS DIMINISHED BILATERAL. INCREASED 02 TO 4L PER NC PER PRN TITRATION ORDERS. DUONEB BREATHING TX ADMINISTERED. ANXIOUS AFFECT BUT HE DENIES ANXIETY. POX IMPROVED SOME AFTER BREATHING TX 88%-91% WITH O2 AT 4L PER NC AND STATES HE IS STARTING TO FEEL BETTER. LUNG SOUNDS CONTINUE DIMINISHED BILATERAL. RESIDENT C/O BACK PAIN BEHIND HIS LUNGS. VS 98.4 102 22 128/82. DR. NOTIFIED OF RESIDENTS CONDITION AND WAS INSTRUCTED TO SEND HIM TO ER FOR FURTHER EVAL. CALLED ER TO CHECK ON STATUS OF RESIDENT AND WAS TOLD HE HAD A PNEUMOTHORAX(LEFT) AND WAS HAVING A CHEST TUBE PLACED AT THIS TIME AND WILL BE ADMITTED.
3 1/2 large reddened swollen area going around th edeltoid muscle with fever.  Received one shot on this arm.  Mom said he only received one shot in this arm.
6/26/21--;pca;  7/8/21 mild, mildly pruritic , non-painful, bilateral conjunctival injection (left more than right) without ocular discharge--attributed to seasonal  allergic conjunctivitis butstill persists at present time.  7/13/21 woke up with severe (8-9/10) sub sternal and left sided chest pain/pressure sensation, whih radiated to his back with associated difficulty breathing/shortness of breath, worsening of pain with deep inspiration and sling supine, and palpitations.  Bilateral calf pain and tenderness fo left foot. Symptoms persisted.  To ED at Hosptial but left without being seen due to long lines then came to our ED for evaluation. Of note received 1st dose humira without apparent side effects
Site: Pain at Injection Site-Mild, Systemic: muscle twitches random, last about 20 seconds. started in arm,moved to other arm, also in neck.-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient reports experiencing mild headache and nausea, then a couple days after injection started experiencing muscle twitches started in right arm, then left arm, and today started in neck area.  Twitches are random and last about 20 sec.  Patient was counseled on hydration and to follow up with medical evaluation if symptoms persisted continued to move to other locations.
broke out w/active chickenpox 1JUN98 p/vax FEB97;
Fainted for 5 sec, HR 75 bpm, oxygen saturation 99%, recovered w water and oreos
Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms, chest, under her breast, lower back and trunk. She took Claritin and used hydrocortisone cream before coming into the ER. She received diphenhydramine 50mg PO and prednisone 60mg PO in the ER.  she was discharged home with prescriptions for Zyrtec 10mg, Diphenhydramine 50mg a Prednisone taper.
Reports generalized achiness approximately 1-2 days post vaccination, progressed to burning sensation and pain bilateral lower extremities, legs started to feel heavy, difficulty walking, unsteady, involuntary muscle spasms. No sensory loss, no incontinence.  Denies recent illness, Reports previous flu vaccination 2 weeks prior, with concerns about 1/2 dosing as instructed by nurse administering injection, documentation of this dose is not available at this time. Diagnosis: Transverse Myelitis Rx with Solu-Medrol, Prednisone, neurontin, ibuprofen Patient remains in SAC unit. Medical Records received on 2/02/2005 states pt experienced abnormal reflex.
Coughing; Congestion, stuffy nose; patient felt like she has cold/ full blown cold; Headache; Nauseous; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine and on 23 OCT 2021, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine; Lupus; This is a spontaneous report from a contactable consumer (patient) reported for self. A 54-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 23Oct2021 as DOSE 2 (BOOSTER), SINGLE (at the age of 54years) for covid-19 immunization. Medical history included autoimmune disease from 2021 and ongoing (autoimmune disease diagnosed 2 months ago, patient read online that she needs to get the booster to be fully vaccinated). There were no concomitant medications. Historical vaccine included Johnson COVID-19 vaccine (Initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine) for COVID-19 Immunization. The patient experienced lupus on an unknown date in Oct2021, patient initially had Johnson and Johnson COVID-19 vaccine as her initial dose for COVID-19 vaccine, she got the booster dose of the Pfizer BioNTech COVID-19 vaccine on 23Oct2021, coughing, congestion, stuffy nose, patient felt like she has cold/ full blown cold, headache, nauseous all on 24Oct2021. Patient reported that recently diagnosed with auto immune disorder which was Lupus and was also on medications, able to eat but wave of nausea which comes and goes Therapeutic measures were taken as a result of event lupus. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Received vaccine 12/05/06 read a major RX 12/12/06, on 12/14 developed macular papular rash arms legs, neck, face, scalp, vaccine site erythematous with 3" surrounding pustule, malaise , RX with Zytec/2pack. Re eval 12/18 no significant healing of lesions, few new lesions neck, forehead, scalp. Meds to Rifanpril. Bactrim R/O MRSA, Reval 12/21 lesions healing, no new lesions. Diag Skin infection. R/O MRSA. Unclear if related to vaccine.
apparent "superclavicular" swelling; apparent "superclavicular" swelling and pain in that region; high fever (100 F); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 22Apr2021 at 12:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, "hypotheroidism" and high cholesterol. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), enalapril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 01Apr2021 at 12:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Apr2021 at 09:00, the patient experienced apparent "superclavicular" swelling and pain in that region and high fever (100 F). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events apparent "superclavicular" swelling and apparent "superclavicular" swelling pain in that region and high fever (100 F) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
1-28-08 misadministration of Gardasil.  It was documented on the patient's immunization record by an office asst., for pt to receive MCV & Gardasil when in fact the parent requested MCV & Tdap.  Tdap was later administered.  Parent upset over admin. of Gardasil.
at 1000 BP 125/87, P=92, R=16.  Reports burning of her entire tongue and scratchiness at the back of her trhoat.  Denies SOB or selling of tongue or throat.  At 1010 denies that her S and S are worse.  Instructed patient on the need to F/U with her PCP as needed.
Information has been received from a physician concerning a male who was vaccinated with the first, second, and third doses of Rotateq (Lot #'s not provided). Subsequently the patient experienced intussusception and was hospitalized. The patient received an enema, but then had to be opened up to have a small piece of bowel removed. The length of the hospitalized was not provided. Subsequently, the patient recovered from intussusception. No additional information was provided. There was no product quality complaint. Additional information has been requested.    09/14/2007 MR received for hospital DOS 6/5-9/2007 for D/C DX of Intussusception S/P small bowel resection. Infant presented with 1 day hx of emesis and bloody mucus from the rectum. Pt fussy/irritable with intermittant lethagy. (+) dehydration on exam.  Sausage shaped mass palpated in LLQ. Contrast enema unsuccessful in reducing IS.  Taken to OR for Exploratory Lap with reduction of intussusception, ileocectomy, and primary anastomosis. D/C on POD #4. Surgical note reports pt doing well post-op following small and large bowel resection for an unreducible intussusception.
microemboli.; some splinter hemorrhages; erythema and tenderness progressively over weeks of all her finger pads; erythema and tenderness progressively over weeks of all her finger pads; crop is elevated; This is a spontaneous report from a contactable physician. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left arm on 25Feb2021 12:00 (Lot number was not reported) as single dose for covid-19 immunization at age 67 years old. The vaccine was given in a Pharmacy or Drug Store. Medical history included APLA, hypothyroid, obesity, and allergies. The patient was not pregnant. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included warfarin sodium (COUMADIN); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC); all taken for unspecified indications, start and stop date were not reported. No other vaccines administered in four weeks. The patient previously took erythromycin and PCP and experienced allergies to both. The patient previously received the first dose of bnt162b2 intramuscular in left arm on 04Feb2021 12:00 PM (at age 67 years old) for covid-19 immunisation. The patient with APLA on coumadin 1-2 days after receiving the vaccine developed erythema and tenderness progressively over weeks of all her finger pads, crop is elevated (as reported) and some splinter hemorrhages suspect microemboli. Just to left hand, systemically well. The adverse evemts occurred on 26Feb2021 12:00 PM. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given to patient for the events. The patient had not recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact 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 sore arm with the first shot.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 1st dose of COVID 19 VACCINE and the 2nd dose of COVID 19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient stated that his/her arm hurt after two Covid shots and the first shingles shot, and he/she did not feel really any symptoms other than a sore arm with the first shingles shot. The patient reported that everyone's symptoms might vary or might not be symptomatic at all. It was unknown if the reporter considered the pain in arm to be related to COVID 19 vaccine and COVID 19 vaccine. The follow-up would not possible as no contact details were available. For tolerance of second dose, refer case 2021AMR160238.; Sender's Comments:  GLAXOSMITHKLINE-US2021AMR161077:Invalid case GLAXOSMITHKLINE-US2021AMR160238:same reporter
After receiving the shot within 5 minutes I had tightness in throat rapid heart rate and a rash on arm I received the shot in. I started taking Benadryl, I left I went home  , I spoke to my doctor and my sister who is a nurse. I saw my Doctor monday, he did an EKG that came back normal. The next day I saw an immunologist he put me on prednisone, xylol , allegra, That was Tuesday March 9. This time the doctor could hear my heart it seemed off. Tuesday evening my heart was beating fast for hours it was 135 BPM while I'm laying in bed. I went to Hospital, They did another EKG which this time caught it . It took about 5 hours of getting my heart to normal rhythm I was admitted to a Cardiac unit.  I was diagnosed with tachycardia and I'm on medication now.
Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who received vaccine PENTACEL and reported that patient had delay in his PENTACEL schedule, did not receive PENTACEL at age 15 to 18 months as scheduled. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to Booster dose missed. It was unknown whether adverse event occurred after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Flushing, hives, ED visit, non prescription medication  Pt waited approx.10 mins then c/o facial redness/tingling and welts on both forearms. Medicated with Benadryl 50 mg po and ambulatory to ED with this writer.   Allergy: COVID mRNA vaccine Allergy reaction: Hives, high severity, ED visit
Info has been received from a Pharm D concerning a male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). Concomitant vaccination on the same day included a dose of influenza virus vaccine in the opposite arm. Subsequently the pt developed itching, swelling and redness on the underside of his arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm D reported that the pt sought unspecified medical attention. A product quality complaint was not involved. Additional info has been requested.
Not feeling very well; Sweated a lot; Pain on left arm; Swollen left arm; Chills; Feeling very tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax 29SEP97 7hr later pt had local redness & pain (severe) w/left arm;12hr later arm red, swollen, itchy;
She got her vaccine, had the feeling of malaise more towards the end of the work.  She woke up on Wednesday and was having a difficult time urination.  Around 11:00 AM there was blood in her urine, and immediately felt that she had a UTI.  She got an APT with her PCP that afternoon, had a urine sample and came back that it was not bacteria.  It only happened that one day but it was four different times.   She then did not feel well, not much energy, an upset stomach.  On Monday she had achy, chills, slight headache and had researched the AE and was classic and was in bed for 6 solid days.  She controlled the achiness and chills with Tylenol.  She notified her doctor that she was sick, they told her that there was not much they could do.  As the week progressed she knew something was not right, and then got a virtual appointment with the PA and logged everything and said there was not much they could do and if not better then go to the ER on Saturday.  She was not worse over the weekend and did not go to the ER, but by Sunday was a little better, and has progressively started to improve since then.   She was not able to eat for the 6 days and is weak due to that, and is starting to get her energy back.    She has had numerous vaccines she travels and has never had an AE to any vaccines.    She is in location for the winter and plans to go see her PCP when she returns home
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Recvd vax approx 1045am, pt started high pitched screaming approx noon.Mom phoned hlth dept 300pm concerned over pt abnormal behavior.Referred to ER.Pt examined in ER & released approx 600pm,DX:Rxn to DPT- Pertussis component
patient described fully body aches, headache beginning the night after vaccination. The next day patient's arm began to swell near injection site. 3 days later the swelling is the size of a fist, itches and is hot to the touch. Advised patient to contact her pcp.
Unspecific viral infection characterized by skin and mucous membrane lesions Prescribed:  1-prednisone 50 mg.   2- triamcinolone acetonide 0.1 3-doxycycline hyclate 100 mg capsule
pt rcvd vx; pt leg became red & swollen were injection was given; both legs became involved;crying; pt unconsolable for approx 20min;
Started with numbness around the mouth, chin, and cheeks area. Within 1 hour I started to have tingling, pins and needles in my fingers and toes. I felt overall very tired and weak. Within 12 hours I had extreme pain with stiffness in the lower back area, including the muscles along my spine. The next day I returned to the clinic and they sent me directly to ER. I was evaluated by a neurologist and prescribed pain medicine. Today, 5 days post vaccination he numbness and tingling sensations are 70% gone, but my back pain and stiffness is only 10% lower.