chrisvoncsefalvay/vaers-outcomes huggingface dataset:
May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so). At the time of the report, EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during possible pregnancy with no associated AEs for this female patient of unknown age. Patient declined further contact.
Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)
Pneumonia / Died this past week because his body couldn't fight it off; Lungs were congested; Couldn't breathe; This case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included hospitalization (hospital this past month) and sedation (was in a sedative state).   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, 1 day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pneumonia (serious criteria death, hospitalization and GSK medically significant), lung congestion (serious criteria hospitalization and GSK medically significant) and difficulty breathing (serious criteria hospitalization). The patient was treated with oxygen. In November 2019, the outcome of the pneumonia was fatal. On an unknown date, the outcome of the lung congestion and difficulty breathing were unknown. The patient died in November 2019. The reported cause of death was pneumonia.   It was unknown if the reporter considered the pneumonia, lung congestion and difficulty breathing to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in the hospital, and while he was in a sedative state, the patient was vaccinated with a flu shot without his permission, and never even told his wife and kids. The day after vaccination, the patient couldn't breathe, and his lungs were congested.  The patient was put on oxygen, because he got pneumonia. The patient died because his body couldn't fight it off.; Reported Cause(s) of Death: Pneumonia
Numbness in my right foot at the base of my  big toe. Occasional pins and needles and feelings of walking on glass.
Initial report received from a healthcare professional on 17 September 2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, received intramuscularly a dose of FLUZONE QIV batch number: UI158AA (site and dose in series not reported) on 15-Sep-2014. On 16-Sep-2014, patient had congestion, felt achy and had slight fever. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events were reported as unknown. List of documents held by sender: none.
Fever,body aches,massively elevated liver enzymes,prolonged coags all wihin first 48 hrs of vaccine "first dose". Transferred to different hospital after initiating Acyclovir and beginning N-acetylcystiene IV. Transfer by helicopter for feared submassive hepatic necrosis of unknown origin.
Muscle cramps; Pain in lower back moved to buttocks; Fatigue; Diarrhea; Back ache; Fogginess in head; Stiff neck; Felt like a fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 14:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, restless legs syndrome, penicillin allergy and anxiety. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), sleeping aid (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC) all for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 08:00,Next morning fatigue, diarrhea, back ache, stiff neck, fogginess in head. Felt like she had a fever. Better by evening. On 08Apr2021, 2nd morning after shot, woke up feeling even worse - severe back pain, fogginess in head, fatigue, diarrhea again. Pain in lower back moved to buttocks - muscle cramps. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fatigue, diarrhea, back ache, stiff neck, fogginess in head, felt like a fever, muscle cramps and pain in buttocks were resolving at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
first vaccination given 02/13/21 and second 03/13/2021.  Positive 07/09, admitted 07/12 to hospital
Mom noted pt started sleeping longer than usual; tried to wake pt from nap & was unable to do; mom called clinic & was told to call squad & get pt to ER; EMT were able to wake pt p/20 mins; BP was low pt given 02 & taken to hosp; sluggish;
After receiving vaccine he was with me (mom), visiting my grandkids, shopping and eating,  for approximately 3 hours at which time I dropped him off at my ex husbands house where he lived.  Within 30 minutes he walked to his dad and grabbed his chest and slumped to the ground.  Emergency Ambulance was called and attempted unsuccessfully to revive him but transfer to hospital where they worked for an hour.  He was placed on life support and transferred to one of their larger facilities.  On 2-14-21 they did the brain activity test ad he was pronounced dead.  Remain on live support until Core could harvest usable organs
8AUG93 approx 320PM mom screened about pts health status; pt became pale & lethargic; very sleepy & did not arouse easily; R52-pt awaken for approx 3 to 4 mins would fall asleep again; vomitted; cold & clammy became very diaphoretic;
Marked increase/ worsening of his liver labs between 3/17/21 and the next time they were checked on 5/25/21. Patient had two doses of Pfizer COVID-19 vaccine during that time .  First dose was on 4/3/21 EP7533. Second dose was on 5/1/21 ER8736.
Headache, Fever, Nausea, Body aches, tired. Took Tylenol
Case number PHEH2014US024990, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 09-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
PATIENT FELT EXTREME PAIN IN LEFT ARM SEVERAL HOURS AFTER SHOT. THE NEXT MORNING SHE AWOKE AT 5AM WITH SWEATS AND FEELING VERY LIGHT HEADED.
Information has been received from a registered nurse concerning a 30 days old patient who on 04-NOV-2008, was vaccinated with a dose of rotavirus G1 P1 vaccine live (89-12). On 23-DEC-2008, at the age of 16 weeks, the patient was inadvertently vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The registered nurse reported that the inadvertent administration of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was due to nursing error. No adverse effect was reported. Additional information has been requested.
Allergy reaction,  fever, chills, headache, tiredness- lasted around 36 hours
Accidentally gave client 2 Yellow Fever vaccines.  Had client wait 20 minutes after vaccine and no adverse side effects noted.  Called CDC and Sanofi Pastuer Medical Information nurse and called client's father with information.
Initial case received from a consumer on 23 October 2012. A male patient age 15 months received a dose of DAPTACEL Lot # C4186AA, intramuscularly into the left thigh, a dose of FLUZONE Lot # U4531BA, intramuscularly into the left thigh and a dose of PREVNAR, Lot # G10784 manufactured by Wyeth, intramuscularly into the right thigh on 23 October 2012. The patient had a history of eczema, facial rash with egg whites, but tolerates egg yolks. Concomitant medications and lab results were not reported. On an unspecified time after administration of vaccines, the patient held his breath for 10 seconds and then passed out for 1 to 2 seconds. The patient was described to be easily awakened by the nurse practitioner. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
COLD SWEAT, HIGH BLOOD PRESSURE. HE CONSULTED WITH HIS PRIMARY MD AND SHE TOLD HIM THAT IT WAS PROB HYPERSENSITIVITY TO THE VACCINES. HE GETS FLU VACCINES YEARLY AND HAS HAD NO ADVERSE EFFECTS FROM IT. HE BELIEVES IT WAS DUE TO THE FLU VACCINE. MD TOLD HIM SYMPTOMS MAY LAST A FEW DAYS AND HE SHOULD FOLLOW UP WITH HE.
9/20/21-9/23/2021 she would wake up with hives on her back, she would take a shower and they would leave. Then it would start all over the next morning. On 9/24/2021 she woke up with huge hives on back, thought they would go away and they did some but by that evening she had hives appearing on her face and then her bottom lip on one side started swelling. Her scalp was itching and red, hives on back, chest, neck, and face. Went to ER and was given a steroid shot, benadryl, and pepcid. She started improving and was sent home with a prescription for steroids 20 mg 3 once a day for 5 days. We didn't start them because she seemed fine. On Sunday evening the hives came back, so we gave benadryl. We started the steroids on Monday morning 9/27/2021  and after taking them she had no hives and seemed fine. We followed up with her pediatrician on Thursday she didn't seemed concerned at all and said hives can sometimes last for awhile, I wasn't very happy with the visit. We finished the dose Friday morning on 10/1/2021. Started again with hives and itching on 10/2/2021 was given benadryl. On 10/3/2021 at 6 am she was awoken to pain when she would swallow in her chest. She also was nauseous and had hives now on the palms of her hands along with the other areas on her back, face, chest, neck, and head. Her bottom lip was swollen again on one side opposite of the last time. We went to an Urgent care and was prescribed more steroids along with zofran and singular. She is still miserable itching and covered in painful hives. We need help and not sure where to turn. We want her to be back to normal with no itchy, painful, hives. Please help if you know of anything we can do for her. Thank You.
Received the vax at 2 pm by 10 pm I had waves of nausea hot and cold chills and sweats.  For 2 weeks exhaustion the following week servere upper back pain for a week the on 4/3 the shingles!  Still as of today nerve pain ( PHN)
Pt recvd Engerix-B  on 30APR90 & 29MAY90 & 23OCT90 subsequently found neg antiHBS p/3 doses @ 1mo, 2mo & 6mo intervals;
headaches; severe kidney infection; drenching night sweats; Fever; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 as single dose for COVID-19 immunization in an hospital. Medical history included irritable bowel syndrome-constipation (IBS-C) from an unknown date. No known allergies. Unknown if with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication and unspecified generic birth control both start and stop date were not reported. On 31Mar2021, the patient experienced fever and drenching night sweats. On 01Apr2021 the patient developed headaches. On an unspecified date on Apr2021, 4-5 days post vaccination of the first dose, the patient developed severe kidney infection treated with ciprofloxacin. The events required doctor or office/clinic and emergency room visit. The outcome of the events was recovered. The patient received the second dose on bnt162b2 (lot number: EW0164) on 19Apr2021 left arm for COVID-19 immunization.
Initial unsolicited report received from a non-health care professional (patient's parent) on 02 May 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination patient had experienced confusion, meningitis symptoms and hallucinations. It was reported that, patient required a lengthy time of bed rest. Patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment were not reported. The outcome of events was unknown. Upon internal review, the company decided to consider the event serious because of important medical events confusion and meningitis symptoms. List of documents held by sender: none. Sender's Comments: The events meningitis symptoms, hallucinations and confusion are unlisted for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Date of administration of vaccine and occurrence of events were not provided, hence, temporal association cannot be established. Very limited information was provided in this case, therefore, causality cannot be assessed for now.
Had a migraine for days after the vaccine, but not certain if related to vaccine or stress. Went away 02April2021 afternoon.; related to Stress; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; MELATONIN. The following information was reported: MIGRAINE (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "Had a migraine for days after the vaccine, but not certain if related to vaccine or stress. Went away 02April2021 afternoon."; STRESS (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "related to Stress". Therapeutic measures were not taken as a result of migraine, stress.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash/hives that began mostly in extremities and advanced to nearly full body. No response to Benadryl. Fever. Lasted for 4 days or so.
Hives covering left arm chest and torso. Numbness of entire left side of body lasting days.
At a post surgical exam, Dr. noticed a swollen gland on the left side of my neck. She asked about the timing of my second vaccination, which was 6 days prior to my meeting with her.  She told me that it may be related to my vaccination.
Pt recvd 3 doses of an unk Hep B vax & a 4th dose of Engerix-B & did not respond;
The patient has sharp and long lasting pain at injection site and in the arm where the vaccine was injected.  She believes that it was injected too high in the arm. Patient reports her husband got a vaccine also but from a different pharmacist and it was injected into a spot lower in the arm.
About 3 hours after the vaccination I had an intense heavy racing feeling in my chest.  I was doing some outdoor physical activity  at the time.  I was unsure if I would be able to make it back to the house.  When I did get back to the house I laid down. The symptoms lessened but did not go away until the next day.  I had 3 previous Covid 19 Moderna vaccines and did  not experience this type of reaction.  I did have a flu shot a week before this vaccine and no vaccines in the same year as the previous Covid 19 Moderna vaccines. The only other symptoms I experienced on the December 2022 vaccine was a mild sore throat, sore arm at the site of the shot (this happen on all 3 previous shots), and some flare up in previously sore injury spots.
Pt. received vaccine - in less than 24h. developed pain at site, erythema, induration, Temp 103.
The site where I got the shot was red, swollen, and itchy when I woke up this morning. It feels much better now, but I wanted to report it.
Patient felt nauseous, dizzy, sweating and fatigue. She looked pale and clammy. She recovered after 30 minutes.
I contracted COVID 19 01/19/2022 with congestion, runny nose, and fatigue. Recovered after 5 days with only lingering fatigue for 3 weeks.
Symptoms: headache, pain at injection site, nausea and shooting pains o. Neck.
Around 12 noon, approximately 20 hours after receiving second dose of Moderna Covid 19 vaccine I started feeling lightheaded, was unable to concentrate and felt like I was going to pass out, leg muscles became achy and rubbery feeling.  Sat down and put my head down to avoid collapsing.  Sat for about 15 minutes like this and became very warm and began sweating profusely.  Felt nauseous and had dry heaves.  Stood up and put my head down on our sink. (I was at work at the time as a retail pharmacist)  Stayed in this position about another 10 minutes.  Finally my head felt like it was starting to clear so I stood up and was able to walk around the department.  Went back to my workstation and was able to concentrate but then felt very chilled to the point where I started shaking.  This lasted about 20 minutes.  Shaking gradually stopped but then I felt very tired.  Was able to finish my shift 2 hours later, was able to drive home but felt very tired and was having muscle pain in my lower legs (thighs to ankles) and developed a mild headache.  Took one  Aleve (naproxen sodium) tablet around 4pm that afternoon.  Started feeling somewhat "normal" later in the evening around 8pm.  Woke up Sunday 3/14/21 and felt fine.
Rash; flushed; nausea; chills within 2 hrs of vaccine.
Immediately post vax, the pt went limp closed eyes and was unresponsive, although breathing and heart rate continued. Pt underwent observation and monitoring with follow up the next day.
Initially, sore arm, headache, body aches. Shortly thereafter, extreme pain/inflammation in right hip/knee drastically affecting mobility
received the adjuvant only that was not reconstituted with the antigen; received the adjuvant only that was not reconstituted with the antigen; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: received the adjuvant only that was not reconstituted with the antigen) and inappropriate preparation of medication (Verbatim: received the adjuvant only that was not reconstituted with the antigen). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 29 Jun 2023 The nurse reported that they had 2 vials of antigen left in a box of Shingrix so they believed that most likely 2 patients were given The adjuvant only that was not reconstituted with the antigen.  The reporter consented to follow up. The patient only received adjuvant that was not reconstituted with the antigen which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case has been linked with case US2023AMR091993 reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR091993:Same reporter, different patient
Shortly after vaccination, pt developed dizziness and headache. BP 108/90, HR 80, SP02 99%. No signs or symptoms to suggest anaphylaxis. Pt developed CP during her observation period as well. EMS transport to the ED was recommended for evaluation. Pt declined and instead was driven home by significant other. She had mild persistent symptoms at the time of her departure.
Arm is red, swollen, and itchy. Warm to touch. Occurred 48 hours after vaccination. Covered a large portion of the deltoid and across the whole arm.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of VAQTA and RECOMBIVAX HB, (doses, lot numbers and expiration dates were not provided). The vaccines had been exposed to temperature excursion of 34 degrees F during that month. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient instructed to stay seated on exam table after HPV #1 as routine. About 5 minutes later she had very brief few seconds of syncope/near syncope. Was placed supine w/legs raised and elevated. Almost immediately she was completely alert and oriented. VS wnl. No head or any other injury sustained. Patient monitored after episode and did well.
Information has been received from a 78 year old female healthcare worker with chronic obstructive pulmonary disease who in January 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported).  Concomitant therapy included AVELOX, rifampin, ethambutol hydrochloride and metoclopramide (manufacturer unknown).  Subsequently the patient experienced active tuberculosis.  The patient was hospitalized at that time for about 13 days, and then released.  The patient stated that she had also been tired, short of breath, little appetite and gastritis.  Active tuberculosis caused prolonged hospitalization.  Additional information has been requested.
At 5:15 AM, the patient went to the bathroom and collapsed into unconsciousness upon trying to leave. Eventually, she was moved into bed but was only semi-conscious the rest of the day.