chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid vaccine and she tested positive for covid afterwards; Covid vaccine and she tested positive for covid afterwards; This is a spontaneous report from a contactable consumer. This is the second of three reports   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter mentioned his wife's co-worker (patient) also got the Covid vaccine and she tested positive for covid afterwards on an unspecified date, this was shortly after getting the vaccine. On an unspecified date, the patient underwent COVID-19 test with result positive. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100971123 same reporter/drug, different patients/AE
This RN administered Pfizer vaccine in her left deltoid. Patient advised to wait 30 minutes for observation due to history of allergies. Approximately 10 minutes later the patient reported she didn't feel good and felt like she couldn't breathe. Epi Pen administered in left quadricep. 911 called. The patient reported her lips were swollen, her hands and legs were going numb. the patient did not loose remained A&Ox4. Doctor arrived and assessed the patient auscultating her heart and lungs. This RN obtained her 02 sat of 99% and HR of 127. The fire department arrived; assessed the patient followed by the ambulance. The patient reported she regained feeling in her hands and legs.  The patient was transported to hospital.
Pt had 3 tonic clonic seizures within 24 hours of dosing of vaccinations. With period of Apnea after seizure at medical center, transferred to ER seen by medic, and discharged with diagnoses of Febrile seizure, previously had 1 seizure. 8/08/07-records received for DOS-4/20/07-ER visit-hospitalization not required. DX: Seizure, eczema. Temp in ER 37.3.Complex febrile seizure, described as clinching of his entire body perhaps left more than right with eyes frozen in midline. Fever to 101.7 Two additional seizures self resolving.
On 3/31/00, the pt became very irritable and vomited for 10 days. The following week he developed gastritis and diarrhea as did the pt's brother who was unvaccinated.
fever 102F max, headache, body aches, symptoms subsided after a day and a half
Day after 2nd shot of vaccine: generalized muscle and joint aches and soreness, fatigue, mild headache  This lasted all day. Second day after vaccine, just fatigue and mild headache. Third day after vaccine, no further side effects.
This spontaneous report was received from a registered nurse and refers to a 19 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAR-2018, the patient was inadvertently vaccinated with a pediatric dose of VAQTA injection (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. Was stated that the patient should had received the adult dose, however no adverse effects were reported.
Throwing up, body aches, nauseous, weakness and trouble breathing. It started about 1.5 hours after injection
fever, congestion, runny nose, body aches, fatigue. starting 12/16/21
This spontaneous report as received from a pharmacy technician refers to a 39-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 11-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Obtained through report: On 12/15/2021 (approximately 2 months post booster vaccine), client presented to the ED with sudden onset chest pain and shortness of breath. He was admitted to the SICU s/p diagnosis of new onset acute type B aortic dissection. Blood pressures in the ED were 160-180/80 with pulses from 70-80. He was started on esmolol drip with improvement into the <120 range.
Moderate to severe pain and tenderness in underarm/arm put of same side where shot was received. Has been occurring over 48 hours. Believe it is swollen lymph nodes.
Pt exp generalized sz @ home approx 1/2 hr p/immun were given; Taken via ambulance to ER, t105.8 r; Hospitalized x 3 days; Temp taken again on admission 105.6 r;
Patient reports two days after her vaccination for COVID with Moderna brand, blisters and red spots appeared in the area of the administration of the vaccine (left arm) in addition to itching and feeling warm to the touch. Patient reports not having visited the doctor, but on his own began to apply Neosporin in the affected area (left arm). Patient alert, oriented to the moment of evaluation.
Vaccinated pt  (self report) admitted with covid symptoms and positive covid test. No info on vaccine, i.e. date, type, place, etc.
Information has been received from a Registered Nurse concerning a 16 year old female patient who on 23-MAR-2009 was vaccinated with a first dose of GARDASIL (lot# 0702X).  On 28-MAY-2009 she received second dose of GARDASIL (lot # not reported).  On 16-JUN-2009 she began experiencing a headache, nausea, vomiting and diarrhea.  The patient sought unspecified medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Woke up @ 4AM saying things were biting & saw a dog & kitty cat on the branch then said were biting & screamed for 10 minutes; pt was lethargic & hallucinating per mom fever;
Slight chills the night before - 1-13-11 feel really hot, sweating, wave of nausea woke up on the floor, fainted one time only.
COVID-19; PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD). In August 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved and NASOPHARYNGITIS (PATIENT VACCINATED AND STATED THAT IT WAS LIKE A BAD COLD) outcome was unknown.      This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. Reporter causality for COVID-19 was not related and not reported for Nasopharyngitis with Humira.
Day 1- Evening, soreness, redness, very hot to touch, red circle at site 2 1/2 inches diameter. Day 2- Large red circle, extremely hot, treated with cold compresses, no fever, called pharmacy to report reaction. Day 3- Morning, the red circle had expanded to inside of the arm, irregular border, continued soreness, visited Clinic. FNP  made  phone calls to Doctor and  other support colleagues, it was determined the reaction was cellulitis and offered to prescribe antibiotics.  At that time, I decided to see Dr. who prescribed Augmenten  (AMOX-CLAV 875-125MG TABLET # 15, noticed  improvement after 2-3days.
patient was given vaccine about 4:25-4:30 pm 6/30/2019.  patient and husband were in booth after immunization while talking with me.  she said she was fine and they left. she came back almost immediately and stated she just needed to sit down as she felt a little dizzy and as though it was a little difficult to catch her breath.  I asked her if she had ever had a reaction like this before and she said she did once before when she was stung by a bee.  when that happened she took benadryl and felt better.  she sat down and tried to slow her breathing.  she put her head down towards her knees while I got a cold compress for her neck and one for her forehead.  i had her take her jacket off to cool down.  I asked her if she wanted me to call an ambulance or direct her to an urgent care and she said no.  she said she felt similar to when she had the bee sting and asked for a dose of benadryl.  i confirmed with market manager that it was ok to administer 10 ml (25mg) of liquid benadryl.  I checked patient's blood pressure at about 445 and it was 122/73, pulse 79.  Patient said that was slightly high for her.  I sat with her and her husband for a few minutes, checking on her.  After about 15 minutes she stated she was feeling a little better.   I took her blood pressure again when she said she wanted to go and it was 117/71 pulse 78. she stated she felt much better.  we discussed the current symptoms and to call 911 should they exacerbate.  she confirmed she had benadryl if needed.  I advised I would call her tonight to check on her.
Adverse Reaction - rash to site, trunk and back 2 hours after vaccine. Came back to clinic, PCP/pharmacist gave Zyrtec 10mg, Pepcid 20mg, Vitals signs stable
Mother reports to PHN on 5/2/01 and states that child had "fever" (not checked) at 18:30 on 5/1/01 but at midnight, temperature was 104.5F (ax) and given Motrin but same temperature in the morning. Called MD and instructed to use Tylenol. At 13:00 on 5/2/01, temperature had decreased but "going back up". Child had "dry heaves" earlier in the morning with complaint of stomachache now, at 13:00. Child alert. No redness of arm. On 5/3/01, mother reports that fever "broke" on the evening of 5/2/01. No problems today.
Patient reported that everything went well with his shot until two weeks after he got it. Patient stated that he felt a regular shoulder pop  in his left shoulder. His shoulder then felt warm and was red and swollen.   Pt reported that he visited his doctor about the shoulder pain and had imaging done looking for fluid in the joint, of which none was found. Patient reported being informed that this was likely due to aging, however patient requested that the event be reported in case it might be related to the vaccination.   The patient returned today for his second dose of Moderna, 4 weeks after his initial dose. He reports that his arm is still sore, but that he is continuing to use it and wanted his second dose in the same arm, the left.
hives continued; achy feeling in her upper body; metallic taste; itching; Neck Ache; loss of smell; loss of taste; metallic taste; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste), the second episode of DYSGEUSIA (metallic taste), PRURITUS (itching) and NECK PAIN (Neck Ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20H and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and the first episode of DYSGEUSIA (metallic taste). On 19-Jul-2021, the patient experienced the second episode of DYSGEUSIA (metallic taste), PRURITUS (itching), NECK PAIN (Neck Ache) and MYALGIA (achy feeling in her upper body). On an unknown date, the patient experienced URTICARIA (hives continued). On 09-Mar-2021, ANOSMIA (loss of smell), AGEUSIA (loss of taste), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, last episode of DYSGEUSIA (metallic taste), PRURITUS (itching) and MYALGIA (achy feeling in her upper body) had not resolved and NECK PAIN (Neck Ache) and URTICARIA (hives continued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.  No concomitant medication reported.   This case was linked to MOD-2021-265616 (Patient Link).   Reporter did not allow further contact
Tinnitus; Had swelling of hands face and lips 1 hr after Pfizer shot #1; Had swelling of hands face and lips 1 hr after Pfizer shot #1; Had swelling of hands face and lips 1 hr after Pfizer shot #1; Rapid heart beat; Warmth; Flu symptoms; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 05Mar2021 at 13:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included sinusitis and sulfonamide allergy. Concomitant medications included OTC biotin (MANUFACTURER UNKNOWN), serenoa repens (SAW PALMETTO), cholecalciferol (VITAMIN D3) and multi vitamin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received cefaclor (CECLOR) and levofloxacin (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 05Mar2021 at 14:15, the patient experienced swelling of hands face and lips, 1 hour after the vaccination. The patient experienced tinnitus after 2 hours which still existed after 3 weeks and rapid heartbeat, warmth and flu symptoms for 24 hours. The patient did not receive treatment for the reported events. The clinical outcome of the events swelling of hands, swelling of face and swelling of lips and tinnitus was not recovered and of the rapid heartbeat, warmth and flu symptoms was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Awoke with 2 inch circular nonpruritic red patch on right biceps. 2 hours later noted 2 separate hives on right arm itching
Started getting red, itchy, reaction localized to injection site on 6/5/14. Shot given 6/2/14 rash better 6/6/14.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. On 13-OCT-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (lot # K010439, expiration date, dose, dose number and route were unspecified) instead of the intended dose of ZOSTAVAX. No adverse events were reported. Additional information has been requested.
Patient is known to faint after receiving vaccinations. Also endorsed being very anxious being around people. Patient felt hot and dizzy. EMT's evaluated, moved patient to separate and quiet room where she rested on stretcher. Increased wait time, patient felt better at 1155 and left on her own accord.
Rash at injection site and torso. Started as pinpoint rash then increased with time.  Used Benadryl with no relief.  Erythema Multiforme now covering entire body. 11/9/09 Medical records received for date 11/3/09. DX: erythema multiforme. Chief c/o rash on torso and injection site, left thigh 4 days after vaccines. Rash is itchy, (+)loose stools. Assessment (+)rash left thigh.
On 7/24/01, the pt experienced constant crying, and irritability. On 7/25/01 the pt experienced a fever of 103.3 and was admitted to the hospital following care in the ER. Had blood work done, chest x-ray and spinal tap. All were neg. according to Mom. Symptoms persisted for 4-5 days and then resolved. Mom reports that MD did not know what caused the fever.
This spontaneous report was received from a nurse regarding a pregnant female patient of unknown age. Pertinent medical history and concomitant medication was not reported. Patient had no drug reactions/allergies. On 11-JAN-2018, patient received the first dose of GARDASIL 9 intramuscularly for prophylaxis. On the same day, the patient underwent pregnancy test. On 12-JAN-2018, the pregnancy test results received which was positive. The nurse was unsure of the pregnancy gestation. No adverse effect was reported.
On June 17th, after the injection I just had a sore arm which is typical. When I woke up around 8 am on Friday the 18th, I had full body muscle soreness and a headache. As the day went on, my headache got worse and felt really fatigued and tired.  Still had the full body muscle soreness all day. By around 11:45 pm on the 18th, I was throwing up.  I went to bed and woke up around 5 am on the 19th still with a headache. I took a migraine pill and some Advil and has  since subsided  so far and full body soreness is gone.
Pink bruising on index finger; Sore arm; Headache; Aches and pains; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Pink bruising on index finger), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concomitant products included FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness). On 26-May-2021, the patient experienced CONTUSION (Pink bruising on index finger). On 24-May-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness) had resolved. At the time of the report, CONTUSION (Pink bruising on index finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27 May 2021 included: Lot no and contact information updated.
This was my booster.  -Fatigue 4 hours after injection  -Fever recorded 16 hours after injection (100.3) lasted 2 days -On and off headache for 2 days -Chills (fever related) and body aches for 2 days -Intense under arm (lymph node) pain lasted 3+ days ?Pain just to the touch -Swollen under arm (lymph node) lasted 3+ days ?Pain just to the touch -Red and swollen injection site lasted 3+ days -Pain in injection site (which was expected)
Chills; Muscle pains; Fatigue; Headache; Joint pain; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever). At the time of the report, CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was not provided by the reporter.
Lethargy/fatigue, chills, soreness at injection site. Soreness and lethargy lasted approximately 3 days after the vaccine was administered. Chills lasted just the first day that the vaccine was administered.
The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023; No adverse event; Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date.) and PRODUCT STORAGE ERROR (The vaccine got expired on 12-Mar-2023 and was intially stored in the refrigerator on 13-Mar-2023).    No concomitant medications was reported. HCP stated that a dose of the Moderna COVID-19 monovalent vaccine was administered to 2 patients after the expiration date. No adverse reactions have been reported by any patients for this invalid dose. It was unknown whether its Individual vials or intact cartons.  The size of vial was 5.5 ml which was initially stored in the refrigerator on 13-Mar-2023.  The vial did not undergo any temperature excursions. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715335:other patient, same reporter
devel itchy red bumps on lower back, abd, halfway down thighs;pt states that bumps were about the circumference of  pencil eraser;