chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up about 9 days after vaccination with a very red, puffy shoulder. No pain, no itching, nothing.  Later my husband realized it was the same arm that I had the vaccination in. We immediately looked it up (google) and sure enough there was a long article by a doctor who called it "COVID Vaccine Arm"  The time frame and symptoms she discussed were exactly like mine.  There was even a picture of an affected shoulder that looked exactly like mine.  At any rate, her article indicated that it should go away in 4 or 5 days and sure enough, about 3 days later it started fading and 2 days after that, it was gone.  It gave me absolutely no discomfort at any time.  It was just an oddity but her article said that it should be reported.
patient stated about 12 hours after immunization she woke up with a severe headache, itching, weak feeling and pain, thirsty, cold, fever and chills. She stated 12 hours later she was back to normal with only a weak feeling that she has all the time without regard to the immunization.
pt recv dtp/orimune. pt developed swelling of lips and blotches over body.  seen w/i 48hrs of vax by md.  blotches disappeared, but small amount lip swelling remained.  Pt treated w/ sus-phrine inj and tavist syrup.
Patient presented to ED with 3-4 day history of of increasing dyspnea, generalized weakness and cough. She was diagnosed with COVID-19 and is current inpatient for treatment.
No additional AE reported.; temperature excursion; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour 0 minute 0 second. On 07-FEB-2023 (also reported as 15-FEB-2023, contradictory information), the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (rHA), lot #W019627, expiration date: 19-DEC-2023, administered intramuscularly at right thigh for prophylaxis at private doctor's office/hospital (dose and strength were not provided) (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:
Patient received MCV4 in Left deltoid and Tdap  in Right deltoid on 5/12/09. She came in 5/18/09 c/o left upper arm itching for a few days (approx started 5/15/09). Noted reddness & bumps on 5/18/09 so came into clinic to be checked. On exam of Left upper arm, found erythemam, increased warmth and flesh colored papules below injection site. Also had scaly white mark where bandaid had been. Right arm unremarkable. Applied small amount OTC hydrocortisone cream to area and ice pack applied.  Patient returned later in day and said itching had resolved. On exam reddness and warmth had resolved. told to watch and monitor and return if symptoms return.
3AM very warm temp; took Ibuprofen. 8AM fatigue, vomiting, and no apetite.
SEVERE PAIN IN LEFT SHOULDER AND ARM. PCP SUGGESTED MOTRIN 200 MG A DAY FOR 3 OR 4 DAYS. ER ON NOVEMBER 5, 2017 WEANING DOSE OF PREDNISONE 10 MG/SLING/EXERCISE SHEET. PCP SENT HOSPITAL FOR 6 XRAYS, SETUP HOME PHYSICAL THERAPY, ORTHOPEDIC REFERRAL/ORTHOPEDIC PRESCRIBED MOBIC 7.5 MG 1 TO 2 A DAY FOR 30 DAYS, ORDERED MONTH OF IN HOME PHYSICAL THERAPY. GO BACK 1/11/2018 IF NO IMPROVEMENT, WILL ADMINISTER CORTISONE SHOT.
Muscle aches, chills, rigors, fever -started 12 hours after injection. Lasted 15 hours.  Intermittent headache and nausea- same time period as above.  Fatigue- started 6 hours after vaccine. Lasted about 36 hours.
Callers sister had taken the first dose of the covid vaccine, and her inner ear has inflammation; experiencing vomiting; dizziness; This is a spontaneous report from a contactable consumer or other non-healthcare professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization. Medical history included face paralysis. The patient's concomitant medications were not reported. It was reported that patient had taken the first dose of the covid vaccine, and on an unknown date her inner ear has inflammation, and she also experienced vomiting and dizziness and scared to take the second dose because she might go back to having face paralysis and wanted to know what to do. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
According to patient, approximately 4-5 days after receiving the Shingrix vaccination, she developed two lesions on her face (on the right side, near nose and mouth) and one on her trunk (left side). She described them as itchy, hot, fluid-filled lesions which eventually crusted over.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included not menstruated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number.  No concomitant medications were reported. On 12-MAR-2021, the subject experienced menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual bleeding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Starts around 4 pm.  Lot of pain right side of face like:  1.  toothache, whole jaw aches   2.  neck arthritis   3. sinus infection  4.  ear infection all at the same time.  Strong pain all through right side of face, sometimes up through eye.  Worse lying down.  Cause?   Dental exam complete mouth x-rays indicated no problems with any teeth.  Saw Dr. 3/3/2021, was checked for ear, sinus infections, felt all around my neck, no problems.  Prescribed gabapentin, told to continue the Tylenol Arthritis I had been taking on my own.  Symptoms continue today, only right side of face, head, temple area, sometimes up through right eye, teeth on right side ache.  Only take the Tylenol once a day since that is all that I need it.  More painful if I lie down in bed at night so sit upright until pain is gone; then sleep through the night.  No problem all during the day when I?m up and around doing whatever. . .no pain then.  Someone in my dental office has the same symptoms along with Bells Palsy, was told by her doctor it's from the Covid shot and could last 3 months? Pharmacist also told me filling the gabapentin for several others with same symptoms (I live in a small town).
1 week after vaccination, developed hot red arm and itching, palm sized rash. NO generalized rash or itching. NO cough, wheeze, throat tightness. Today is 5th day of symptoms--improving 85% improved, but not resolved.
The HCP stated the patient was supposed to receive their scheduled dose of "GSK's Hep B vaccine, Engerix, but that the nurse confused the products and administered the wrong vaccine; The HCP stated the patient was supposed to receive their scheduled dose of "GSK's Hep B vaccine, Engerix, but that the nurse confused the products and administered the wrong vaccine; no adverse effects were repoerted; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient.  The patient's medical history, concurrent conditions included, concomitant therapies and previous drug reaction were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml/once, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) instead of and  hepatitis b vaccine rhbsag (yeast) (ENGERIX) (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) it was mentioned that it was unknown if the patient received the schedule dose or if was missed (Wrong vaccine administered) as per nurse confused the products (product confusion). No additional adverse event were reported.
Pt came to ER c/o SOB, chest pain, and feeling of knots all through his back.   EKG done STEMI alert activated.
She just turned 17 and the health department gave her maderna shot; She was so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was so sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was so sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot). At the time of the report, ILLNESS (She was so sick) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-significant follow up appended
Patient made online appointment for Covid Vaccine. On immunization consent form, she noted that she didn't have any allergic reaction to another vaccine or to an injectable medication but she has allergy to sunflower, flaxseed, and latex. So she received Pfizer vaccine. 9 minutes after the vaccine, patient started to feel itchiness on her face especially around the nose and mouth, then she felt it going down to her chest. Vaccinating pharmacist noticed that the patient was getting redness around patient's neck, she called other pharmacist and they both went to talk to the patient. When patient was asked about symptoms that she was feeling, patient mentioned that it was the itching that bothered her the most. She denied that she has difficulty breathing or dizziness. So I drew up 1 mL of diphenhydramine and injected it IM to the other arm. Pharmacist watched her for another 20 minutes in the room. Patient kept complaining about the itchness but no other symptoms. Patient called her husband to come and pick her up. Patient was instructed to take benadryl at home if symptoms persist. And patient was also instructed to see medical help if symptoms were getting worse. Husband came and picked up the patient and patient went home
This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a patient who received TWINRIX. On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: A second dose in a TWINRIX 0, 1, 6 month schedule was delayed.
Patient had a red area growing from the site of the injection that was hot, painful, and swollen.
lower back pain; Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and ARTHRALGIA (Hip pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BACK PAIN (lower back pain) and ARTHRALGIA (Hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain) had not resolved and ARTHRALGIA (Hip pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-062528 (E2B Linked Report). This case was linked to MOD-2021-062528 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Tylenol added as treatment drug. Anatomical Location added. Outcome updated to not resolved for back pain. Action taken updated to no change. Company causality updated to possible for back pain.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062528:dose 1
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "previous cancer patient (10 years ago)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient had no known allergies. Patient was treated with Paxlovid (from 24Mar2023 to 27Mar2023) for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300144614 Same patient, different product and event;
Red place on arm approximately 5" by 2.5" retangular. Hot and firm to the touch.  Patient did not inform place of vaccination for 4 days and tried to treat with rubbing alcohol and hydrocortisone cream.
Rash at injection site that is red, itchy, warm that is worsening as the days progress. It is shaped like a ring. Suspect it is "COVID Arm".
1-2 hrs after vax, arm swelling, had heaviness in chest, nausea, "throat felt swollen". Then, began w/headache, abd. pain. Fever began 11/20/99 also, and is 102F today. Today, left uppr arm laterally is warm, swollen and tender.
Headache; Extreme body fatigue; Muscle aches; Had difficulty sitting up or lying down unless lying on a hard floor; Felt like I was going to pass out; Heart palpitations; Two panic attacks; Chest pains/Felt like heart attack; Shortness of breath/Felt like heart attack; Increased severe anxiety; Depression; This is a spontaneous report from a contactable Healthcare Professional. A non-pregnant 51-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 29Mar2021 10:15, at 51 years of age, (Batch/Lot Number: ER8733) as single dose, for COVID-19 immunization. Medical history included hyperthyroidism, allergy to shrimp, menopause and allergy to IV dye, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (Batch/Lot Number: EN6206) on 08Mar2021 10:00 AM, at 51 years of age, administered in left arm. Concomitant medications included levothyroxine 25 mcg, progesterone and estradiol, all taken for an unspecified indication, since an unknown date. The patient didn't receive any other vaccine in the previous 4 weeks. She wasn't diagnosed with COVID-19 before vaccination. The patient reported that on 29Mar2021, after the second dose she had severe headache; extreme body fatigue; muscle aches; and had difficulty sitting up or lying down unless lying on a hard floor for the first 3-4 days after vaccine. For 3 weeks she continued to have severe continual headache; extreme body fatigue where if she tried to exercise or simply walk dog or go up flight of stairs she felt like she was going to pass out; she also had heart palpitations and two panic attacks, all of these symptoms lasted 3 weeks after vaccine. She went to the emergency room twice: once for headache and chest pains (as she felt like heart attack); second time it was for shortness of breath, again she felt like heart attack, she had to call for an ambulance. All these instances increased severe anxiety and panic and interfered with her work and daily functioning until 24Apr2021. She then began to feel herself again. However, she was still experiencing anxiety, depression, and panic at times. The patient underwent lab tests and procedures on an unknown date in 2021, which included CT scan, chest X-ray and EKG, with unknown results. The patient was tested for COVID-19 via nasal swab on 23Apr2021, which was negative. The patient was treated with headache medication. The events headache, extreme body fatigue, muscle aches, had difficulty sitting up or lying down unless lying on a hard floor, felt like i was going to pass out, heart palpitations, chest pains and shortness of breath recovered with sequelae on an unknown date, whereas the events two panic attacks, increased severe anxiety and depression had not resolved yet at the time of the report.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 29-SEP-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 04-SEP-2012. Lot# was reported as 0709AE, expiration date: 04-JAN-2014. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (3 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursion) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from same source. 1209USA007525 1209USA008597 1209USA008598 1209USA008599 1209USA008600 1209USA008601 1209USA008602 1209USA008603 1209USA008604 1209USA008605 1209USA008606 1209USA008607 1209USA008608 1209USA008609 1209USA008610 1209USA008611 1209USA008612 1209USA008614. Additional information has been requested.
pt recvd vax & devel t 105; tx w/ apap & cool bath;
near syncope, hypotension, shaking. Lasted 20 minutes in clinic with stable BP, HR, and  SpO2 mostly >96%. Dipped to 88% a few times. no respiratory symptoms, rash, or throat swelling. transferred from clinic to ED via ambulance
I had chills, muscle aches, and I fainted when I got up to the bathroom, breaking my ankle.
Pt recvd vax 25JUN94 & 16AUG94 & on 21FEB95 presented to hosp & was dx w/pneumonia & a lt pleural effusion; BC revealed H. influenza type B; pt was transferred to another hosp for acute care; addtl details are being requested;
Patient reports that soreness/tenderness did not occur until 4 days after the injection. Throbbing pain/tender between deltoid and elbow. No visible reaction.
lt shoulder swelled, inc & dec & around shoulder would not move arm, restless @ noc; temp was elevated; devel rash on lt chest near joint on 14JUL93 still appeared @ noc;
Soreness in injection site that began from time of 4/2/21 injection and lasted until the morning of 4/4/21. Aches that began approximately 4 hours after injection and resolved without ibuprofen by the next morning 4/3/21. Fatigue began about 3 hours after injection and lasted until the morning of 4/4/21. Some slight nausea occurred the evening of vaccination and continued until the next morning 4/3/21
Patient developed fever >104, significant lethargy - difficult to arouse and unable to stay awake, rash on face and head  Fluid bolus, benadryl IV, acetaminophen IV , solumedrol IV,  rash resolve and symptoms improved.
Physician states the 4 month old received Quadracel and Hib today instead of the Pentacel he ordered with no reported adverse event; Initial information received on 04-Nov-2021 regarding an unsolicited valid  non-serious case received from a physician via Medical Information (MI) number: 00843731.  This case involves a four months old female patient was received HAEMOPHILUS INFLUENZA TYPE B VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE,  PNEUMOCOCCAL VACCINE CONJ, DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID for Immunisation.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number: C5763AA and expiry date: 28-8-2022 via unknown route in unknown administration site and a dose of suspect HAEMOPHILUS INFLUENZA TYPE B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to wrong product administered (latency: same day).  At the time of reporting, no adverse event was reported.  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 the 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.