chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant and received 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose) in a 22-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Craniosynostosis with youngest child). Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics, Allergic reaction to antibiotics and Drug allergy. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jun-2021. On 07-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose). On 07-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory test includes Dating ultrasound-Normal , Anatomy ultrasound-Normal, Ultrasound to look for Craniosyntosis- Normal .  Medical history include Craniosyntosis with youngest child.  Concomitant medication include iron supplement.  No treatment information was provided.
No adverse effects were reported in the patient.; a patient received a vaccine following a temperature excursion; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On 26-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (strength was reported as 25/0.5; dose, route, lot #, expiration date were unknown) for prophylaxis, which had been following a temperature excursion (lowest temperature below 36 degrees Fahrenheit/2 degrees Celcius (35 degrees Fahrenheit) for 430 minutes) (incorrect product storage). There was no previous temperature excursion. No data logger was involved. No adverse effects were reported in the patient.
I woke up with a slight fever and a sore arm that got progressively worse as the day went on, I am now feeling Nauseous and my joints ache specifically my lower back. I keep having to move my arms because they keep falling asleep/getting tingly.
It's just a discomfort; pain; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she was due to receive the second dose on 25Feb2021. She wanted to go to the orthopedic doctor to discuss an underlying medical condition. She wanted to know in case she was to receive cortisone shot, if it would it impact the efficacy of the vaccine. She stated "I am going hold off going to the doctor. It's doesn't bother me as much. It's just a discomfort. I am not in excruciating pain. I will wait and take Tylenol for the pain. However I won't take Tylenol right before my shot." The events occurred on an unspecified date with outcome of unknown.  Follow-up attempts are completed. No further information is expected. Information about the batch/lot number cannot be obtained.
Classic Herpes Zoster(shingles) left T5 and T6 dermatomes. Received injection at 10AM and noticed rash when I got home from the hospital at 8:00PM same day. Not likely related but felt should report any; rash; This is a spontaneous report from a contactable physician (hospital based neurologist) reporting for a himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #ELO140) via an unspecified route of administration in left arm on 18Dec2020 10:00AM at single dose for COVID-19 immunization. The patient received the vaccine in hospital. Medical history included coronary artery disease (CAD), status post stent placement right marginal branch in 2015. The patient had no allergies outside of seasonal. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced classic herpes zoster (shingles) left T5 and T6 dermatomes and noticed rash when he got home from the hospital at 20:00 on 18Dec2020, same day of vaccination. The patient started on valacyclovir (VALTREX) 1 gm every 8 hours for treatment of events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. The reporter considered not likely related but felt should report any.; Sender's Comments: Classic herpes zoster (shingles) /rash occurred on the same day of vaccination with BNT162B2 represents a coincidental viral infection caused by Herpes zoster, unrelated to the vaccine use.
Client received vaccine on 11-4-05 at 4:30 pm. On 11-9-05, he started to have itchiness, with no redness, that was unrelieved by Benadryl. It later developed that night into hives on his arm and both legs. He had welts on his legs and arms. He also complained of chest pain. On 11-9-05, he went to urgent care. On 11-15-05, he still had some itchiness and redness, that is helped by Zyrtec.
Large, red, itchy rash around injection site that appeared 7 dates after vaccine administered. No treatment given.
p/vax pt devel knot approx size of ping pong ball; extremely sore; some redness; lasted 4 days
I tested positive for COVID-19 in 02/2023. I had a fever of 102, cough, and tightness in chest. I took an at home test and tested positive. I contacted my doctor and requested a PCR test and tested positive again. I was not prescribed medication, but I took Tylenol. I am feeling better now, but I still feel very weak. I feel like I have lost some muscle in my body. I lost about 10 pounds. I am also losing my train of thought from time to time.
3/1/07: Fever 103, onset in a.m., sib with documented Influenza Type B by rapid Ag test. Treated with Tamiflu x 5 days.
Diffuse skin rash, macular, only mildly pruritic.  Started day after vaccination.
Approximately 10 minutes after receiving a Tetanus injection , patient began to experience cold sensation in her abdomen, dizziness, nausea and vomiting. Patient received supportive care, to include fluid challenge, vital sign observation.
Painful red and swollen x 4 days; better today but continues and now itchy. Used ice and Motrin.
Headache; muscle soreness: convulsive chills comparable to hypothermia lasting four hours with muscle fatigue lasting another day.
Patient came into clinic with brother for Child Health.  Patient was due for #2 HPV.  Patient was given her brother's vaccines instead and received a #2 Menveo-had first at age 11 and a Bexsero.  No adverse reactions noted.  Patient was scheduled back to receive correct vaccine.
White blood cell count plummeted from 5.8 to 3.3 within 2 months of receiving the Moderna vaccine, based on bloodwork taken Dec. 2021. Neutrophil count plummeted 4100 to 1310 as well. I am extremely healthy, young with no health conditions.
itchy red spots; Red spots; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced itchy rash and red spotty rash. On an unknown date, the outcome of the itchy rash and red spotty rash were unknown.   It was unknown if the reporter considered the itchy rash and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The pateint received shingrix shot about 2 weeks ago and experienced  itchy red spots in a wide base across her back from waist up to bra band.
Soreness at the injection site after second dose; Fatigue after second dose/Feels extremely tired after second dose; Been taking naps after second dose/Going to bed early after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for an unknown indication.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site after second dose), FATIGUE (Fatigue after second dose/Feels extremely tired after second dose) and SOMNOLENCE (Been taking naps after second dose/Going to bed early after second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-048199 (Patient Link).
Nurse reported VAQTA was administered after improper storage.; This spontaneous report was received from a nurse, concerning to a unspecified age and gender patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, vial, lot #X003791, expiration date: 01-JUN-2024 (who had been verified to be a valid number) administered for prophylaxis (strength, and route of administration were not provided).  On 21-JUL-2023, the vaccine was improper storage at temperature 51 degree Fahrenheit, with a time frame of 1 hour 0 minutes and 0 seconds. There was no information about previous temperature excursion (product storage error).
pt had a positive COVID test on 9/30/21 from Senior Living; 10/8/21 brought to ED with AMS and seizure like activity; pt had to gone to receive monoclonal antibody infusion, but had a change in mental status and was sent to ED before receiving infusion; pt tested positive for COVID in hospital; CT of head showed no acute  findings, chronic left cerebral infarct; given O2 supplementation; pt suffered cardiac arrest twice, intubated, sent to ICU; was then made DNR and passed away in the hospital
a little soreness to his arm where he had the injection; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had his first shot and was scheduled for his second dose on 15Mar2021. The patient experienced a little soreness to his arm where he had the injection. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
When preparing the vial, 1.6mL of diluent (sodium chloride) mixed instead of 1.3mL. The vaccine given slightly weaker due to too much diluent mixed.
High fever of 103.8 evening after vaccination. Diagnosed as adverse fever reaction by ER as no signs of other infection were present.
Patient presented approximately 25 minutes following vaccine with a feeling of swelling in her throat along with throat pain and shortness of breath.  She stated that she has had similar reactions during an asthma attack and also with anxiety.  She was given Benadryl 50 mg by mouth once and observed for 30 minutes.  She was given water to drink and rested comfortably.  Her vitals remained within normal range during the entire event with an oxygen saturation of 99-100%.  She stated that the feeling improved significantly with the Benadryl dose.  No erythema or swelling was observed to lips, tongue, or mouth.
No other AE reported; the infant was inadvertently administered GARDASIL 9; This spontaneous report has been received from a physician referring to a 1 month old patient. The patient's medical history, concurrent condition and concomitant medication were not provided.      On 08-MAR-2021, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis (inappropriate age at vaccine administration). No other adverse event (AE) was reported. The reporter inquired if there was anything for the parents to be concerned about.
pt recv vax 9JUL98 & cried 3+ hr for 4 days;generally very fussy then would scream;
body ached all over; slight headache; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 18Feb2021 (at the age of 63-years-old; Lot Number: EN6198) as dose 2, single for COVID-19 immunisation. Medical history included psoriasis on her skin, psoriatic arthritis, Mild COPD, herniated lumbar disc; all from an unknown date and unknown if ongoing. Patient has ongoing depression and anxiety, for both which she was treated. Concomitant medications included Effexor XR 225 mg and Lorazepam 2 mg twice daily. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 26Jan2021 10:30 (at the age of 63-years-old; Lot Number: EN5318) for COVID-19 immunization and experienced dull headache, chills, fatigue and slept though most of it. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 18Feb2021 15:00, the patient experienced body ached all over, slight headache and extreme fatigue for 48 hours. The events were considered as non-serious. The events were not treated. The outcome of the events was recovered on 20Feb2021 15:00.   Follow-up (PRD 29Mar2021): Follow-up attempts are completed. No further information is expected. The following information was also reflected on the narrative: non-pregnant and age at vaccination of suspect drug. Added age at vaccination and adverse events of the historical vaccine. Updated the dose description of suspect drug and captured stop date of events as 20Feb2021 15:00.
Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (allergic to sulfa) and Trachyonychia (Fast heart rate). Concomitant products included ANASTROZOLE for Hormone therapy, METOPROLOL for Tachycardia.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL PROPRIONATE) at an unspecified dose and frequency and COD LIVER OIL [COD-LIVER OIL] at an unspecified dose and frequency. At the time of the report, ECZEMA (Ezcema/Skin on left leg has become hardened/Dry skin/get newareas of skin rashes on body everyday/spot on the leg leaking/spot on the leg has moisture/areas between fingers are also red/Newred/dark purple spot at at the bottom of her leg) had not resolved.            Patient was taking concomitant medication anastrozole to block a hormone that creates a tumor.  Patient had first dose in mid Apr 2021 and 2nd dose in early May2021  Patient reported that starting in May2022, the skin on left leg hasbecome hardened and there was now a newred/dark purple spot at the bottom of leg and it had moisture and it was leaking at time of reporting. The areas between her fingers are also red and leaking fluid. Patient stated that she was starting to get new areas of purple and skin rashes on body everyday and doesnot want them to get onto face. Patient had consulted with dermatologist who prescribed with Clobetasol proprionate Ointment which did not do any good. Patient  was told that it was eczema or dry skin. Patient used Cod Liver Oil to nourish the skin but it did not do any good as well.   This case was linked to MOD-2021-095308 (Patient Link).
This is an 83-year-old female who presents today with  "weird feeling on her chest" and bilateral ear pain that woke her up this morning. PT headache. No vision changes. No numbness, weakness, or tingling. No dysphagia/dysarthria. Pt says she's unable to quantify for me. Patient says she did receive her booster shot for coronavirus on Friday. Patient says she did have a bloody nose yesterday. No cough or shortness of breath. Patient does have a significant past medical history for a sending aortic aneurysm last seen 4.7 cm. Patient follows with heart doctor.
After patient received the vaccine it looked as though he went into shock.  His eyes were open but was unresponsive and very shallow breathing.  He was jaundice.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Severe aches in my joints and muscles, pronounced weakness and fatigue, red, watery and pussy eyes, extreme continual headache and sinus congestion. (I was unable to work)
It's also got a couple of little blisters in it; hands swelled up; arthritis; burning itch; rash on my stomach/now it's on my upper arm/more rash around the main welt/skin rash; burning itch; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (It's also got a couple of little blisters in it), PERIPHERAL SWELLING (hands swelled up), ARTHRITIS (arthritis), VACCINATION SITE PRURITUS (burning itch) and RASH (rash on my stomach/now it's on my upper arm/more rash around the main welt/skin rash) in a 67-year-old female 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (It's also got a couple of little blisters in it), PERIPHERAL SWELLING (hands swelled up), ARTHRITIS (arthritis), VACCINATION SITE PRURITUS (burning itch), RASH (rash on my stomach/now it's on my upper arm/more rash around the main welt/skin rash) and VACCINATION SITE PAIN (burning itch). At the time of the report, BLISTER (It's also got a couple of little blisters in it), VACCINATION SITE PRURITUS (burning itch), RASH (rash on my stomach/now it's on my upper arm/more rash around the main welt/skin rash) and VACCINATION SITE PAIN (burning itch) outcome was unknown and PERIPHERAL SWELLING (hands swelled up) and ARTHRITIS (arthritis) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 included NNI.
COVID; COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. Clinical course: Patient experienced inefficacy after receiving covid vaccine. So, he got Pfizer. The first dose, yeah, he thought was like [Date]. The second was [Date]. Got COVID In August.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.