chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on tummy and under arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on tummy and under arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (hives on tummy and under arm). The patient was treated with CORTISONE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (hives on tummy and under arm) had resolved.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant Follow up, event outcome updated to recovered.
Information has been received from a physician concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live (OKA/Merck). In January 2006, the patient developed varicella with 20-30 lesions. She was treated with Acyclovir and was noted to be recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Tha day after vaccine given pt had redness, swelling temp 100.7, and getting worse. Was seen in the clinic on 6/1/15 - had cellulitis. treated with cephalexin for 7 days.
Information has been received from a medical assistant concerning a 3 year old patient w/ NKDA who on 03/91./99 was vaccinated with varicella virus vaccine live. On 07/18/01, the patient presented to the doctor's office with "break thru chicken  pox", a papular rash and a few vesicular lesions on the torso, extremities and task. Additional infomation has been requested.
AS SOON AS I GAVE THE VACCINE TO THE PATIENT HE PASSOUT WITH IN SECONDS,AFTER 1 MINUTE HE BACAME NORMAL BUT HE WAS SWEATING REAL BAD
Patient was administered the Janssen COVID vaccine at 403 pm. I returned back to the pharmacy to prep his partner's vaccine and when I came back at 405 pm, he was loopy with his head swaying. He wasn't responding to verbal communication by his spouse and me nor through touch as I shook his shoulder. He then lost consciousness and so I lifted his head to check for breathing and pulse which he had. I asked my technician to call 911, and asked my other tech to help me transition him to the floor so we can raise his legs to provide blood flow to his head. Mid-transition, he had a seizure. We brought him completely to the floor and just as I was about to turn him to his side, he regained consciousness. Pupils were dilated, breathing normal, pulse elevated. He also was able to speak immediately and confirmed feeling "okay". I then had my technician remain outside with him laying on the ground as I returned back inside the pharmacy to call management and my technician was still on the phone with EMS. Paramedics and management arrived within 10 minutes upon which patient was then taken to the hospital. Wife followed and we rescheduled her vaccine.
Pain at site of shot; feeling tired; headache; vomiting; fever. From 5/10 through 5/11/2018. Tiredness, headache, vomiting and fever subsided by 11PM on 5/12/18 after taking 325 mg TYLENOL every 4 hours.
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD Lot # N010865, expiration date 01-OCT-2018 (doses, routes and frequencies were not reported) for prophylaxis; that were reconstituted with properly stored sterile diluents (doses, routes and frequencies were not reported). The average temperature of excursion was reported as 13.3 Fahrenheit (F) (also reported as between 6F and 14 F), during a time frame of 2 hours. There was no previous temperature excursions. No adverse effects reported. There was a Digital Data Logger involved.
Debilitating dizziness that has NOT yet fully resolved (14 weeks and counting). Nausea (3 weeks), extreme fatigue (3 weeks), headaches (ongoing), vision disturbances (3 weeks), ringing and fullness in the ears (ongoing), anxiety (3 weeks), high blood pressure (2 weeks), inability to concentrate (8 weeks), brainfog (8 weeks) and muscle soreness in neck and shoulders (ongoing).    Treatment was only provided for dizziness. Diazepam, medrol pack, and propranolol. None have resolved the issue. Vestibular therapy (2 weeks) and ongoing chiropractic treatment.
she experienced pain; felt horrible / felt terrible; felt sick; could not eat or drink; could not even move to use the restroom; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she experienced pain), FEELING ABNORMAL (felt horrible / felt terrible), MALAISE (felt sick), FEEDING DISORDER (could not eat or drink) and HYPOKINESIA (could not even move to use the restroom) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Back pain.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PAIN (she experienced pain), FEELING ABNORMAL (felt horrible / felt terrible), MALAISE (felt sick), FEEDING DISORDER (could not eat or drink), HYPOKINESIA (could not even move to use the restroom) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (she experienced pain), FEELING ABNORMAL (felt horrible / felt terrible), MALAISE (felt sick), FEEDING DISORDER (could not eat or drink), HYPOKINESIA (could not even move to use the restroom) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test was negative.         No concomitant medications was provided. It was reported that the adverse events lasted few days 2 to 3 days. Consumer states that because she was taking Tylenol, she could not take her back-pain medications.   This case was linked to MOD-2021-290917 (Patient Link).
Right upper lateral thigh with 5x7 inch erythema, warmth to touch, and discomfort.  Mother reports that child also had itching over site and on chest.  No fever, chills or other symptoms.  Mother had not medicated child.
p/vax T98.8, c/o generalized pain;12:00 T101.6-two APAP PO given;11/8/99 12:24 T99.4;11/8/99 330PM c/o severe h/a & body ache, T99.3;c/o h/a worse & body ache;flushed, weakness, resp rapid, shallow, c/o lungs hurt;hosp w/pneumonia & UTI
pt recv vax 21JUL96 & 22JUL96 pt exp vomiting, hot & cold spells & dizziness;the episodes lasted approx 2 hr then resolved;
Information has been received from a physician who reported that she had received a telephone call from an obstetrician. The obstetrician indicated that his child was vaccinated with Hep-B vaccine recombinant (yeast) and died of sudden infant death syndrome (SIDS). Since that time, the obstetrician had started a web site of Hep-B vaccine recombinant (yeast) and SIDS cases. The obstetrician reported that he had 40 cases (WAES 01050372) in his web site. The physician also reported that an infant vaccinated with Hep-B vaccine recombinant (yeast) developed cyanosis, jaundice, vocal cord damage and gastroesophageal reflux disease (WAES 01042680).
Myalgia, Fever, chills, flank pain Narrative:  2 days of flank pain n/v and chills runny nose itching at injection site after #2 dose
Surrounding deltoid muscle aches/pain with some on/off finger numbness.  Difficult to raise left arm 90 degree plane.
Urticaria - Diffuse Pruritis Erythema Significant Edema improved with Benadryl
She got her vaccine, it hurt a little bit, was burning.  It was more painful going in than the Heb A-B that she got on her left arm, and she had no problem with her left arm.  As the day went on it started to swell and get warm.  She had a bit of tiredness with it, nausea and a headache.  As the days went on since then she has gotten quite swollen on the arm, red and itchy and sore.  She has been taking her Tylenol with Codeine that she takes for her spine and neck, she did not take an antihistamine.  It's not a bad reaction for her as when she gets a bee sting or penicillin she gets anaphylaxis.  She saw the pharmacist and wanted her to see the reaction and she knew about it, and she reported it to VAERS on it.
Agitation, Headache, Myalgia, started with headache, then dizziness, feeling anxious; then fatigue and muscle aches for 2-3 days Narrative:
After i received my vaccine 11:00am, i was ok until 8:30 PM, i started to unusual to my body, particularly in my stomach. I didn?t hqve the appetite to eat. By 2am, i woke up with chills and my body was shivering. Temperature 98.3, i took tylenol ES. After an hour, my chills went away. I feel lack of energy.  This morning, i still have feelings of being cold, body malaise and mild headache and still no energy to do house chores.
patient received an Adacel Vaccine that had been frozen and thawed, no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224076, 2019SA224136, 2019SA224137, 2019SA224141, 2019SA224142 and 2019SA224145 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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.  Documents held by sender: none.
Felt confused, spacy, apathetic and out of sorts psychologicall; Flutters of light in the corners of eyes; Blood coming out of nose; Arm started itching; Nauseous/continues to feel nauseous every day; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Blood coming out of nose), CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall), OCULAR DISCOMFORT (Flutters of light in the corners of eyes), PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day). On 06-Apr-2021, the patient experienced EPISTAXIS (Blood coming out of nose). On an unknown date, the patient experienced CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall) and OCULAR DISCOMFORT (Flutters of light in the corners of eyes). At the time of the report, EPISTAXIS (Blood coming out of nose), CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall), OCULAR DISCOMFORT (Flutters of light in the corners of eyes), PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided
Patient is an immunized previously healthy 12yo male, who presented from a hospital with hypotension unresponsive to fluid in the setting of receiving 2nd COVID vaccine one day prior to presentation. Per parents, patient was in his usual state of health until yesterday (8/13) evening, when he woke-up from a nap feeling unwell. He complained of nausea, dizziness, headache, myalgias, abdominal pain, lightheadedness, fatigue, chest tightness and some difficulty breathing with deep breaths. He had gotten his vaccine that day at 12 pm. He was found to be febrile to 103F so he went to another Hospital where he was febrile to 102.5 on arrival. No emesis, diarrhea, or medications taken at home for symptoms. Mom reports he had a similar reaction to his first COVID vaccine, but did not require hospitalization. No known sick contacts and no known COVID exposures. Has pain localized to the left knee after "playing sports.", but no trauma. Patient was never tested for COVID or symptomatic, but Mom suspects that he could have had COVID previously given she had it previously.  He had no hives, wheezing or tachycardia but presented with clear hypotension. He received IM epi, and then was placed on epinephrine infusion. He required 2 days of vasopressor infusion, had mild increases in his inflammatory markers and received an empiric course of antibiotics.  He had no evidence of LV dysfunction or coronary artery ectasia/dilation. He had no conjunctivitis, rash, lymphadenopathy. His inflammatory markers downtrended and he was discharged home.
Information has been received from a physician concerning a female patient of unknown age, who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed fever of 102 degrees after receiving PNEUMOVAX 23. On an unknown date the fever of 102 degrees improved and the outcome of the patient was reported as recovered. The relatedness for fever of 102 degrees was unknown for PNEUMOVAX 23. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to multiple 6 month old patients of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The medical assistant reported that on unspecified dates, for about a year, her practice had been routinely administering an initial dose of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) to patients at the age of 2 months, a second dose at the age of 4 months and a third dose at the age of 6 months. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Fluvirin with Thimerosal given to OB pt.  LMP: 04/06/2009.  EDC: 01/10/2010.  Pt does not have an ob/gyn.  Pt notified on 11/6/09.  Denies any adverse effects.  Pt NOT hospitalized after receiving H1N1 vaccine. 11/25/09 OB records received. Normal OB visit pt. 30wks pregnant. Received H1N1 vax. FHT (+)142.
hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported. No lab data has been provided by the reporter.
Patient requested to receive a COVID-19 booster (Moderna) however, she was mistakenly administered a TDAP (Boostrix) by a pharmacy intern. Patient hasn't experienced any debilitating or detrimental  side effects after receiving the TDAP vaccine; patient resides in good health standing.
Swollen lymph nodes under left arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLOVENT), montelukast sodium (SINGULAIR) and unspecified multivitamin; all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 27Apr2021, the patient experienced swollen lymph nodes under left arm. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes under left arm was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to yeast).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses). At the time of the report, HYPERSENSITIVITY (She received both doses of the Moderna vaccine and had an allergic reaction immediately following both doses) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment includes First line treatment The vaccination facility treated her symptoms on site. First line treatment were reported.   This case was linked to MOD-2021-386571 (Patient Link).   Reporter did not allow further contact
During administration the needle was not far enough into muscle and when syringe was depressed vaccine squirted out and not administered into patient. Vaccine was re-administered to patient.
Severe burning in both right and left feet, tightness and feeling of 'swelling' in both calves, pain in left arm and left side of neck, with exquisite sensitivity at base of skull on left side of head in area of sub-occipital, fatigue, tinnitus, sensation of heat in hands, although they were cold to the touch, chills. Did not take temperature. About 15 minutes after shot was administered, became dizzy, and hot, asked to lie down and was told there was no place for me to do this. Was given a bottle of water and a Hershey kiss and asked if I had eaten that day. Remained at center for 45-50 minutes until feeling well enough to drive home.  Awoke at 2:30 a.m., felt almost panic-y, had severe burning in both hands and both feet and legs. Drank a glass of water and went back to bed after deciding that there was nothing much to be done. Started taking acetaminophen 500 mg that morning and took two more throughout the day. Did the same the following day. Legs and feet still burned constantly and there was no relief, even if lying down. Still experiencing the same symptoms in legs and feet, although most of the other symptoms have gone away.