chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/13 Patient appears to have had very mild allergic reaction to COVID vaccine booster shot that she received yesterday. Patient was advised to continue to take Benadryl every 6 hours to help with eyelid swelling. Patient will also be started on Medrol Dosepak and Pataday eyedrops to help with pruritus and swelling. Patient was advised that if she develops any scratchy throat or shortness of breath she must be evaluated in the ED immediately. 2/3 31 yo female presents to the emergency department for possible allergic reaction. She reports that on 1/11 she received the Moderna booster vaccine (received johnson&johnson initially) and the next morning woke up with swollen eyes, lips, and difficulty breathing. She saw her PCP at that time and received medications including steroids to help with the allergic reaction. She reports that today she woke up again with swollen eyes, lips, and some tightness in her throat as well as a rash on bilateral hands. She took 1 benadryl this morning. She denies receiving any new medications yesterday; no new detergents, lotions or soaps; and no new food intake in last 24 hours. 2/5 Allergic Reaction      C/o itchy throat, eye swelling, rash and slight SOB. Started suddenly around 2000. Administered epi pen around 0100. Sx have improved since epi. Has had 3 episodes of this since Moderna booster on 1/11.  2/15  31 F with PMHx PCOS and allergic reaction to Moderna shot as documented by Allergy specialist presenting for c/c of allergic reaction. She received her Modernal booster shot 1/11/22 after receiving J&J in March. She had an allergic reaction with rash on arms and legs as well as swelling of her eyes and lips. She had been seen by Allergy on 2/8/22 who recommended Zyrtec 10 BID and to be worked up for systemic diseases. Today, she felt her throat getting scratchy and some lip swelling, so she injected herself with an EpiPen around 1300. She is feeling better now, with some residual scratchy throat 2/23  Shortness of Breath     Pt reports received Moderna vaccine about a month ago, was sent in by PCP for an "ongoing allergic reaction".  Was told to come to ED for breathing treatment.  Pt also reports difficulty sleeping and swollen eyes.
Information has been received through the pregnancy registry from a 32 year old female with no past medical history or allergies who on 08/07/2001 and 10/02/2001 was vaccinated with the first and second doses of varicella vaccine. There was no concomitant medication. Around mid December 2.5 months post-vaccination, the pt became pregnant. Subsequently post-vaccination, in approximately 2001, the pt did not develop antibodies. The pt sought unspecified medical attention. Follow-up info from a physician and a woman in the physician's office noted that on 01/24/2002 and 01/28/2002, the pt had an ultrasound that showed a "subchorionic bleed" which was described as "very small in the ultrasound report." The pt was referred to a perinatologist due to the findings of the initial ultrasound and the vaccine exposure. It was reported that a notation from the perinatologist's office stated that the pt had a repeat ultrasound on 02/25/2002, which showed that the subchorionic hemorrhage had resolved, volume fluid was good, fetal heart rate was 162 and normal, and that the fetus was 11 weeks and 4 days gestation. There were no anomalies observed. It was noted that the pericatologist recommended a repeat level II ultrasound at 18 to 20 weeks. The pt's last office visit was  on 03/06/2002 and she was reported as "doing OK." It was noted that the pt had no previous pregnancies. It was unknown if the pt was tested for varicella antibodies prior to vaccination, had a local reaction at the vaccination site or developed varicella or herpes zoster symptoms. The woman in the physician's office noted that the outcome of pregnancy form was in the pt's chart for completion at delivery. Additional info has been requested.
pt admitted to a local medical center on 9/22/21 for delerium, combativeness; in ED found to be positive for COVID; given monoclonal antibodies; productive cough; afebrile, not hypoxic; admitted to hosp for hypokalemia and COVID; treated with Vitamins C, D, and zinc; DNR; dc'd to a private home with hospice where she passed away
patient stated that she started having chills and fever 8 hours after the vaccine; she report a temperature of 100.6 she stated that she urinated all night after having the vaccine and lost 3 pounds the day after the vaccine, she reported that her oxygen saturation was 89 and 90 and all she could do was sit all day. she states that normally her saturation is 95.  She also reported using her rescue inhaler throughout the day.  The day after the vaccine she also stated that her blood pressure top number dropped to 92.  She reports that her normal blood pressure is usually 128-130 over 68-70.   She stated that the 2nd day after the vaccine she began feeling more normal and she only used her rescue inhaler 1 time.. I spoke to her today 7/27/22 and she stated that she feels back to norma.
Narrative:  Patient received 3rd covid Pfizer vaccine on 12/2/21 while at the  facility for follow up with his PCP. Patient was diagnosed with lung cancer in Oct 2021 and had been referred to an outside oncologist. He began chemotherapy sometime in November 2021, further oncology details unknown. Patient had 1st and 2nd dose of Pfizer covid vaccine on 03/30/21 and 4/20/21 respectively. There were no reported adverse effects after the 1st or 2nd covid vaccine. The hospital was notified of an unattended death of the patient on 12/3/21, not considered suspicious. It is more likely that his cause of death was poor health status due to lung cancer. No known history of COVID-19 infection.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 08:50am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
2 vaccines. Syncope episode in office with some tonic-clonic movements 20-30 seconds sent to ER. Full work up done and released.
the morning after i got the shot i woke up feeling paralyzed like my body weighed 1000 lbs. i could move but it was very hard. whole body aches..horrible headaches nauseated
This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a day after receiving SHINGRIX, the patient experienced fever, blood sugar increased, nausea, shivering and general body pain. On an unknown date, the outcome of the fever, blood sugar increased, nausea, shivering and general body pain were unchanged. It was unknown if the reporter considered the fever, blood sugar increased, nausea, shivering and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in the left arm in the evening of a day before reporting. On 6th September 2018, the patient woke up at 5:00 AM with 102 degree fever, shivering, body ache, nausea and increase in blood sugar. The patient would follow up with his physician and gave permission to contact his healthcare provider. No further details were provided.
Pt screamed,threw up, & had diarrhea which has continued 4-6 times per 24 hrs. Parents checke with daycare & were told no other children were ill.Mother is to take pt to MD today.Tx w/ Tebamide for vomiting.
2220-pt medicated with Benadryl 25 mg ivp, and Solumedrol 60 mg ivp. Pt wife reports she gave him a flu shot at home at 2000 this evening and noticed that pt started to get some hives. Pt exhibits shob, hives all over. 10/13/10 2223 FLU SHOT APPROX 8PM C/O HIVES, THROAT SWELLING, WHEEZING, HAD FLU SHOT IN PAST W/O RASH.
Patient appeared to have a vasovagal response to vaccine administratoin. She almost immediately passed out after her HPV#1 immunization, which was administered after Hep A#1.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
About a week after being vaccinated in 10/03, pt states he got very weak, then later nauseated with occasional vomiting. He saw a doctor  was started on Zoloft, which didn't sit well with him. He saw a doctor in a different state in 1/04.
Besides general injection sight pain, muscular aches and fatigue, I have begun to experience enhanced/extreme anxiety upon the 2 day after receiving the Moderna booster shot. I also seem to be experiencing bouts of dizziness and general faintness.
Initial unsolicited report received from a pharmacist on 20-Oct-2015. This case involves two patients (age and gender not reported) who were vaccinated with FLUZONE (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, two patients developed very stiff arms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
pt got vaccination at pharmacy and then later that day at 2 pm couldn't remember that he had been to the store. pt experienced short term amnesia. He went to the hospital and they did all the tests and such on him but couldn't find anything wrong . pt came back to normal around 6 that evening.
Information has been received from a female who was vaccinated on an unspecified date with a single dose of Zostavax (Oka/Merck). It was reported that approximately on 11-JUL-2007 she developed hives. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
almost killed me, had a severe allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot and it almost killed her The patient had a severe allergic reaction. The patient thanked god as her husband and her son found her when the allergic reaction was experienced.  The doctor in the hospital said it was from the shingles shot. The patient further stated that she would never ever get the shingles shot again. Additional Supportive Information: The follow up would not possible, as no contact details were available.
85 recruits were vaxed w/Td & Yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was previously experienced;
I was positive for COVID-19 on 10MAR2023, I had severe sore throat, Itchy ears and a horrible runny nose. I had a low grade fever up to 104 even with Tylenol, I had extreme fatigue and lost appetite. I also, had body aches for about 3 days. I called my doctor and he prescribed Paxlovid, I started feeling better about 5 days later.
Information has been received from a consumer concerning her cousin's 4 year old child who on an unspecified date "a couple of years before" was vaccinated with a dose of MMR II (Lot# not reported). It was reported that on an unspecified date the patient developed autism and it was attributed to the MMR II. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
Had MMR-V on 5/2/2014 (no other prior immunizations) - a couple days later broke out in a red, raised, pinpoint rash circumferential at base of neck. Approx 1 wk. after rash and immun. had caught URI sx.; on 5/27/14 rash still present. Not spreading - mom stated it had "come and gone" during past few weeks.
p/recv vax pt turned very pale (while asleep) x 10 minutes per mom;then the same episode happened again (10min) while asleep ;no other s/s such as fever/shaking of limb/apneic or cyanosis;
Dizziness; Muscle aches; Headache; I felt like a Mini Covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I felt like a Mini Covid), DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced SUSPECTED COVID-19 (I felt like a Mini Covid). On 03-May-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache). At the time of the report, SUSPECTED COVID-19 (I felt like a Mini Covid), DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC was not filed) This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 23-OCT-2017, the patient was vaccinated inadvertently with an expired dose of PROQUAD lot # M019232 and expiration date 17-OCT-2017 (dose, frequency and route of administration) for prophylaxis, which was reconstituted with a properly stored dose of sterile diluent(manufacturer unknown). No adverse effects were reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total (first dose) administered on 2021 for prophylactic vaccination. Age at time of vaccination 38 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAY-2022 at 1:30, the patient experienced suspected COVID-19 infection (symptoms reported as vomiting, diarrhea and fever), and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint.; Sender's Comments: V0: 20220514073-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
pt was observed scratching approx 6PM; a few hives were noted; devel fever during the noc; eyes were swollen- 1 swollen closed; had clear watery nasal discharge & watery eyes; no resp distress; dx ear infect;
In January 2023 I noticed I was very tired.  I was very worn out.  I was nauseous and vomiting and also had diarrhea.  I had body aches, too.  On or about January 13th, I went to the doctor and tested positive for COVID-19 and was given antibodies.  I felt better after a couple of days.  After that, I began to feel bad again and I tested positive for the flu.  I still have a nagging cough that I cannot seem to get rid of as well as a bit of COVID-19 brain.
Approx. 20 minutes, post vax, the pt began a high-pitched scream that lasted for nearly 24 hours. He had fever, redness and swelling at the shot site and tenderness. The doctor was called and she said to give him Tylenol. Dx'd with high functioning autism; sensory integration dysfunction; PDD (NOS). Per doc 213503, developmental delays, behavioral problems. Autism spectrum disorder. Per follow up it is unknown if pt has recovered. There are developmental delays that are present (still) we don't know if he will ever catch up.
Cough, Wheezing, feeling of throat discomfort ("pain"), 2 hives on chin all within 8-10 minutes of vaccine administration.  Patient returned to exam room, was examined, above findings were noted, pulse ox was 95%.  Given 0.3ml of 1:1000 adrenaline im into left deltoid.  Patient was then transported to Medical Center by EMS.
Left arm had hard lump and he was unable to move his arm.  Severe pain rated at 10/10.
This spontaneous report as received from a mother refers to a 16 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as one year ago) and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown of the patient had sought medical attention. Additional information has been requested. This is one of several reported received from same source.
Phizer-BioNtech COVID-19 Vaccine EUA pain at site of infection.  Fatigue, maliaise, dizziness, nausea, low grade fevers
Patient complains of left chest pain when moving her left arm. Feels tender. Pain scale 5/10 when left alone. Pain scale 8/10 when she moves her arm. Paramedics responded. Vitals stable. No known allergies to any medications. Takes levothyroxine for hypothyroidism. Refused medical transport and signed AMA form
upset stomach; diarrhea; fever; chills; aches; tired; arm sorness; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. In December 2019, 36 hrs after receiving Shingrix, the patient experienced upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm. On an unknown date, the outcome of the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, diarrhea, fever, chills, pain, tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right deltoid. On 3rd December 2019, the patient experienced upset stomach, diarrhea, fever, chill, aches, tired and arm soreness. The outcome of events were reported as not recovered/not resolved in the database however in source document, it was mentioned as recovering/resolving.
Chest pressure /  pain lasting 20 minutes unrelated to physical exertion. It resolved after a period of rest.   I will get an EKG at next regular physical.
pt's exp diarrhea-started PM & had emesis today about 11PM noted red rash (red bumps everyone) & feels a little warm; redness fades & brightens; rash all over especially abdo & face;
An hour after I had the second Maderna, my heart started racing rapidly and hard. I almost called 911 but felt foolish. It lasted what seemed like a long time.
Adverse event happended a few days after the injection, we do not have the specific information for patient's reaction at the time.
Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender.; Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender.; It's on my neck, arms and legs. Red, raised, itchy bumps.; Measles type rash started this morning; This is a spontaneous report from a contactable Consumer. This consumer(patient) reported that, A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 19:30 (Batch/Lot Number: FC318Z) as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination 49-years-old). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right On 26Jul2021(07:00 PM) (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 49-years-old) and not received any other vaccine within 4 weeks. Medical history included Controlled high blood pressure and if covid prior vaccination: Yes, from an unknown date and unknown if ongoing. Concomitant medication included metoprolol tartrate (METOPROLOL XL) 25mg, acetylsalicylic acid (ASPIRIN (E.C.)) and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken within 2 weeks of vaccination. Patient was not pregnant at time of vaccination. The patient Noticed a swollen lymph node that is tender in the lower curve of my neck today that is tender on 07Sep2021(10:00 AM) and Measles type rash started this morning and has progressively gotten worse today. It's on my neck, arms, and legs. Red, raised, itchy bumps on 07Sep2021(06:00 AM). For treatment, she did not take nothing and not been tested covid post vaccination. Outcome of the events was not recovered.