chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) 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 02-Feb-2021, the patient received first 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 02-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up  received on 22-APR-2021. included no new significant information.
In notes that I received: HEPATITIS B VACC 20MCG/ML (REC) 1ML SYR, INJECT 20MCG INTO THE MUSCLE ONCE AN IMMUNIZATION DOCUMENTATION NOTE MUST BE ENTERED WHEN THE IMMUNIZATION IS ADMINISTERED. I am not sure of the type of Hep B vaccine or the manufacturer.  As far as adverse effects, the muscle (bicep) where the injection was given has had a numb or dead feeling since the afternoon of the day the injection was given. The skin has feeling but the muscle is tingling on and off and has the feeling of being "asleep". It has of right now been five days that this has been going on.
BOOSTRIX and SHINGRIX given left arm about 2 and 1/2 inches apart (vertical) on Friday June 15th 3:11PM. Fatigue (moderate) on Sat with no visible reaction or weakness of muscle. Sunday woke up in morning and variable shaped red, hot area around injection site was evident, irregular shape (approximate 4inches vertical by 2 and 1/2 inches horizontal approx), larger on top (SHINGRIX on top) than on bottom injection site. Patient complains of heat on that area but still no muscle weakness or pain. Feeling ok energy-wise and happy that she was able to get the shot. Read that the effects she was having were expected and relatively common.
Patient complained of itching 2 hours after injections, rash described as "welts" on chest and neck.  Shortness of breath with exertion and bilateral hip pain developed approximately 24 hours later along with fatigue which has persisted along with other symptoms as of phone call on 10-5-06.
This spontaneous report received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L04226; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
on the verge passing out/lightheaded/dizzy; nauseous; brain fog; This is a spontaneous report from a contactable consumer, patient. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 22Apr2021 (at the age of 32-years-old as a single dose for COVID-19 immunisation.; doxycycline monohydrate, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has not been tested for COVID-19 post vaccination. On an unspecified date, the patient experienced on the verge passing out/lightheaded/dizzy, nauseous, brain fog, and. The patient stated, I am having an adverse reaction to taking a prescribed antibiotic doxycycline after getting the COVID vaccine. When I take the antibiotic since having the vaccine. I feel lightheaded, nauseous, brain fog, dizzy and on the verge of passing out. I am no longer taking the antibiotic but wanted to bring this reaction to the attention of others. These reactions are not from the vaccine alone but specifically occur as a result of taking the antibiotic and exist in addition to the normal side effects of the vaccine.  The action taken in response to the events with doxycycline monohydrate was unknown. No treatment was provided for the events. The patient was recovering from the events, on the verge passing out/lightheaded/dizzy, nauseous, and brain fog.
Patient had sudden onset of rolling of eyes, unable to hold head, and unresponsive 10 minutes after vaccination. Pt was at home and went to ER; from there pt sent to hospital. 8/25/09 MR received for DOS 8/17/09 with D/C DX:  ALTE-possible reaction to vaccines or reaction to pain.  Pt presented after episode of unresponsiveness, limpness and eyes rolling back in the car on the way home from vax provider.  Returned to baseline after ~ 5 minutes. Admitted for observation. PE WNL. further episodes.
flu shot was a disaster, arm had no strength but had awful pain in every move for 9 long months; Initial information regarding this unsolicited valid non-serious social media case reported by consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involved a patient of unknown demographics who reported flu shot was a disaster, arm had no strength but had awful pain in every move for 9 long months (Vaccination site pain), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on arm for prophylactic vaccination.  On an unknown date, the patient reported flu shot was a disaster, arm had no strength but had awful pain in every move for 9 long months (Vaccination site pain).  Relevant laboratory test was not reported.  Final diagnosis was flu shot was a disaster, arm had no strength but had awful pain in every move for 9 long months.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Phone call from Mom states that the child woke in morning diaphoretic, flacid, groggy, lethargic. Wanted to drink excessively. Took to ER, (Had Bolus of fluid). On 10/8/00, mom calls again and states Pt is afebrile. On 10/9/00, called to follow up and Mom stated he was perfectly fine, eating, sleeping. Mom states had low grade fever for 2 days after shots.
Arm was tender to touch, unable to move affected arm in certain directions. Very limited motion to affected arm. Unable to perform daily tasks.
...initial soreness and decreased motion in her shoulder and upper arm. She then noticed a large area of erythema on her upper arm today. She notes that she has reduced soreness and increased range of motion today. She denies any itching but notes that there is some tightness around the erythema. There is a large 5-6 cm oval area of erythema around the injection site, which is slightly rasied. Erythema is ligher and there is no warmth to palpation.
Headache with sharp shooting pains in temples, chills, low grade fever 100.6, body aches especially knees
Awakened with eye pain, severe light sensitivity, tearing.  On 1/21/2021 I went to visit the optometrist and was immediatley referred to the  opthamologist for a same day appointment. I was told it looked like a herpetic keratis (HSV 1 virus) by both physicians. I have a left corneal transplant. I have never had an HSV virus affect my eye in the past. The last fever blister I had was > 5 years ago.  Treated with maxitrol qid, Acyclovir five times a day, Cyclogel bid. Severe light sensitivity resolved after about 24 hours.  On f/u appointment on 1/26/2021 he said that the herpatic lesion was looking better. Eye pain resolved. I am continuing medication.
Stuffy nose; Dry cough; Slight fever; small bump on the injection site; This case was reported by a physician via call center representative and described the occurrence of fever in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th September 2021, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 25th September 2021, 8 hrs after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced fever and injection site swelling. On 28th September 2021, the patient experienced nasal stuffiness and dry cough. On 26th September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the nasal stuffiness and dry cough were not recovered/not resolved.   It was unknown if the reporter considered the fever, nasal stuffiness and dry cough to be related to Pediarix and Pediarix Pre-Filled Syringe Device. The reporter considered the injection site swelling to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the physician. The physician reported that the patient received his Pediarix vaccine. The physician reported that the patient experienced a slight fever of 99.5 degree F approximately 8 hours after receiving the injection. The physician also reported that there was a small bump on the right thigh at the injection site. The physician reported that the mother of the patient texted him that the patient, as of this morning  had a stuffy nose and a dry cough, but otherwise doing well. The reporter consented to follow- up. This case is linked to the case US2021203776, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203776:same reporter
couldn't lift arm; headache; nausea; pain in hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in hand), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm), HEADACHE (headache) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in hand), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm). At the time of the report, PAIN IN EXTREMITY (pain in hand), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR document attached
Within within 2-3 hours was dizzy and fatigued, since that day progressive feelings of exhaustion and little balance.
Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash; Diarrhea; A sore right arm (her injection arm) and could not move it; A sore right arm (her injection arm); Nausea; A fever of 99.9F; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash), DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer (Metastatic breast cancer survivor .).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F). On an unknown date, the patient experienced ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash). On 25-Mar-2021, DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F) had resolved. At the time of the report, ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.9 (High) 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  They gave her a topical medication that took care of the rash.
TOOK VIVOTIF RIGHT BEFORE A MEAL; This spontaneous case report (PVX2019-2313) was received from a physician on 10-Sep-2019. It described an adult female consumer who "took Vivotif right before a meal" (PT: Product administration error), while being on oral Vivotif capsule (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took all the doses of Vivotif on an empty stomach but ate breakfast right after each dose.  Action taken with Vivotif was not applicable.  The clinical outcome was unknown.  Company's Comment: The causality of the event "took Vivotif right before a meal" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took Vivotif right before a meal" was considered as not applicable.
Shortness of breath that came on after vaccine was given. Patient reported it came on after 20 minutes of getting vaccine but was not exactly sure how long it took.
Site: Redness at Injection Site-Medium, Systemic: pain and warm to touch on the injection site-Medium, Additional Details: patient states she's getting better everyday and taking tylenol helps
pt recv vax 10/13/97 & pt exp swelling of the middle finger & arm of the inj site as well as mild alopecia;pt conceived 12/18/97 LMP 12/18/97 EDD 9/11/98;
Large, red,  raised rectangular area. Developed next am, following vaccine. Painful and lasted x 7 days. Even pain into shoulder area. Had completely resolved after 1 week.
This case was reported by a pharmacist and described the occurrence of inability to breathe well in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject experienced inability to breathe well and visited the emergency room. Product complaint was reported as particles were found to be floating around in the syringe. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of inability to breathe well was unspecified. The pharmacist considered this event probably related to vaccination with ENGERIX B. The reported indicated that two subjects experienced an inability to breathe well following administration of ENGERIX B where particles were found to be floating in the syringes. The following was reported with regard to the ENGERIX B product received and stored at this facility: The average temperature of the refrigerator was 4 degrees Celsius, there were no temperature excursions, the temperature was monitored daily, the product was stored inside the refrigerator, the vaccine was placed in the refrigerator as soon as it arrived, the status of the temperature tag upon receipt was not known and the product was shaken well. The linked case number is A0952401A.
My skin started burning icy hot and was sensitive to touch. It's not disabling, but it is irritating. The symptoms are worse at night and have been ongoing since November 23, 2022. My doctor prescribed Methyl Prednisone. I started it last week. I'm finished with it now. I did general lab work yesterday, but I do not have the results yet. I have my regular appointment with my doctor next week.
#1. Injection site pain---3 hours after injection, starts injection site pain, progressivly worsening and last for 48 hours. difficult to raise the left arm #2. chills/low grade fever--started around 9 pm 12/18/20,  received by Tylenol and ibuprofen, reoccurring  after 6 hours, it lasted for about 36 hours #3. severe headache--feeling pulsating pain, starting around 9 pm and relieved by Tylenol and ibuprofen, but reoccurring after 4-5 hours, lasted about 36 hours #4. body aching, especially the lower extremities, coincidence with fever/Headache
Patient received Tdap vaccine in (R) deltoid on 3/11/14. She states her deltoid was swollen and red and stated she thinks she had a reaction to the Tdap vaccine.
pt recv 3 IPV 1964-5&OPV 1967-74;12 YO pt dx w/immunodeficiency synd;tx included infusion of FFP 1975-81;jul81fever 104,diarrhea & general weakness;4 days later stiff neck,diplopia & generalized paralysis requiring ventilation;dx polio
Less than one hour after receiving COVID-19 vaccine, patient arrived at the ER stating her face felt hot, lips tingling/swollen and chest red. Denies any issues with breathing.
persistent severe fatigue; increased skin sensitivity new autoimmune/Hashimoto hypothyroidism
Pt was admitted on 6/1 for abnormal EKG and acute on chronic combined systolic and grade 2 diastolic CHF.  On 6/9 he developed a cough, low grade fever, and hypoxia that required oxygen.  He was found to be COVID positive.
Generalized maculopapular rash within 2-3 days; This is a spontaneous report from a contactable physician via Medical Information Team. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included hepatitis C viremic, cirrhotic. Concomitant medications were not reported. The patient was on hepatic transplant list. The patient developed generalized maculopapular rash within 2-3 days of receiving COVID-19 vaccine. The patient did not experience liver enzyme worsening and was fine at the time of report. The patient asked whether she should get the second vaccine dose. The event resolved with corticosteroid treatment. The outcome of the event was reported as resolved on an unspecified date.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Booster had swelling Ang itching within three hours of injection. No fever at this point. Did not have this reaction prior. Short was one day after hizentra treatment. Doing fine with otc but felt it should be reported
Information has been received from an other health professional concerning an 18 year old white female patient with allergies to aspirin and ibuprofen who on 27-MAR-2007, at 15:00 was vaccinated IM into the left deltoid with a first dose of Gardasil (Lot# 656051/0244U). Concomitant therapy included ORTHO EVRA. That evening, the patient experienced fever, weakness, trouble breathing and pain at injection site. The patient stated that she was in bed for about two days. It was reported that the patient did not report these reactions until she came in for her second injection which was not given. Unspecified medical attention was sought. On 29-MAR-2007, it was reported that the patient recovered. No product quality complaint was involved. Additional information is not expected.
My COVID-19 symptoms started on 02/09/2023 around 02:00am in the morning. It started with chills then through out the day I had cough, sore throat, body aches, fatigue, headaches,  and nasal congestion. In the same morning I took a COVID-19 at 2;00am which was negative. I took another COVID-19 home test on 02/10/2023 at 07:00am which was positive. At 9:00am -10:00am I went to the clinic they did rapid test which was positive. They didn't prescribe me since I wasn't at the risk. I took over the counter medications such as Ibuprofen, Nyquil and Dayquil, Sudafed, Allegra as per needed. On 02/21/2023 I tested negative.
The first 3 days after the vaccination, I didn't feel safe driving, my coordination was impacted, I was not able to think straight (heavy brain fog).   I was hoping this would subside, but here I am a month later, not being able to remember my own friends names, not able to do simply Math, I feel as if the vaccine may have caused some brain swelling.
Patient had pain in shoulder and bicep. She had numbness below the elbow and her two last fingers on the same arm.
8 DAYS FROM RECEIVING MODERNA FIRST SHOT. SHOT SITE ON LEFT ARM RASH AND EXCESSIVE SWELLING. NO OTHER SYMPTOMS.  IS IT NORMAL TO HAVE SIDE EFFECTS BEYOND 7 DAYS? ICED ARM, WILL GO TO EMERGENCE ROOM IF DEVELOPE FEVER OR OTHER PROBLEMS.
I went to bed at 08:30pm, which was very unusual for me. I started to shake violently, and my teeth were chattering. Then I woke up in the middle of the night and developed a fever. Every time I took a deep breath, it would hurt. It was hard for me to hold my urine. I took a Tylenol for the fever. My resting heart rate went up to 80. Eventually, my fever went away. However, for several days, I felt very weak and fatigued. I barely had any energy and it's been hard for me to gather my thoughts or think clearly. Also, my appetite has decreased.
Tactile fever-night of vaccination, swelling, erythema, warmth and tenderness at site (of (L) thigh, MMRV placed), and lack of appetite-vaccine placed 6/25/18. Mom presented with patient 6/27/18-as above and with worsening symptoms.
After 1st dose had severe sciatic pain down both legs to knees.  After about 3 wks pain subsided.   A month later I took 2nd dose (3/2/2021)within 12hours-have had hand issues-trigger fingers, tightening of hand joints.  Not able to make fists unless working hands.  Still continues to this day.
Information has been received from a registered pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported) subcutaneously.  After three days post vaccination the patient developed injection site welts.  As of 07-JAN-2009 the present patient's outcome was unknown.  Follow up information received on 12-JAN-2009 from the registered pharmacist indicated that at the time of the occurrences he did not think to record any information of the patient.  The reporter said that on an unspecified date the patient recovered.  Additional information is not expected.
Febrile seizure lasting >5 hours; found unresponsive, limp, in respiratory distress around 0145; taken to ED where resuscitation occurred, ultimately diagnosed as seizure after ATIVAN given around 0730am which broke seizure.