chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg was swollen, red and hot to the touch around injection site. The area was 4" in diameter . He was irritable and tired the day and day after (today) the shot. His leg is also swollen. I gave him ibuprofen before bed to help with the soreness. I have yet to see if this will worsen or improve as we are still in the early stages.
Pt stated she felt lightheaded. Denies SOB, chest pain. She stated that she did eat breakfast this morning and thought she may have been hungry and needed to eat lunch and she thought it may be indigestion. Gatorade and water given to pt and pt tolerated well. BP checked 120/80, HR 95. PT advised that if symptoms persist go to urgent care or to the closest PCP. PT verbalized understand and stated she felt fine to leave.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-May-2020 and the estimated date of delivery was 05-Feb-2021. On 28-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  forty-first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.      Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated Reporter information and vaccine dosage information
Within 30 days of receiving my second dose of the COVID19 Phizer/BioNTech vaccine I started to get my period approximately every 14 days. Additionally, my emotional state fluctuates dramatically between extremes (happiness, sadness, anger). I have an IUD that has prevented me from getting periods (only get a period roughly once a quarter with the IUD). I never had any emotional side effects from my period. Some days I cry for no reason, other days I have extreme anger. I do feel the emotions are linked to my period, however I feel my period is the side effect of the vaccine. My husband and I did a deep dive into our lives to ensure there were no other causes and the only change in my life was getting vaccinated. As of Dec 2021, I started progesterone to try and mitigate these side effects based on a Rx from my doctor. I have not had a period in the month of December (yet).
CDC reports: 1 yo child developed fever to 102, local rxn at inject site, rash, hives & swelling occurring 30 min p/DPT/OPV immunization. 12FEB90 seen by MD - dx w/strep infect, tx Amoxil 10 day.
place of injection went a little red and a little turgid; place of injection went a little red and a little turgid; the injector injected it in my subcutaneous behind my arm wrongly; This spontaneous report was received from a 22-year-old female patient, who referred to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-NOV-2020, the patient was vaccinated with last dose (the third one) of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) subcutaneous in an unspecified arm (exact dose, lot number, expiration date were not reported) for prophylaxis.  On 27-NOV-2020, after about 24 hours, the place of injection went a little red (injection site erythema) and little turgid (injection site swelling). The patient wanted to know if the vaccine injected subcutaneously (she was not sure, if the needle touched the muscle or not, because the injector injected it angular) would it effect and if it would be ok for her to inject one more vaccine extra for being sure. The outcome of the events was unknown.  The relatedness between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
I woke up from sleep the morning of 12/30/2020 with a very itchy left arm in the area of my injection.   After about 15-30 minutes I was able to fall back asleep.   When I woke up at 6am to get ready for work it felt much better.   Around 9-10am the itchiness returned worsening over time.  At this time I noticed that it was red, hot, and firm in addition to the itchiness.   The application of an ice pack and taking some Claritin seemed to help.     Eventually the itchiness subsided for a number of hours but returned that evening around 7pm.  I took some Benadryl, applied another ice pack, and went to bed.  The next day it felt significantly better, and the area that was previously bright red was now much less red and much less raised.   The itchiness lingered intermittently but not nearly as bad as the day before.   The total duration or symptoms seemed to last for about a day and a half.
burning in feet while sleeping; nerve pain; This case was reported by a pharmacist via call center representative and described the occurrence of burning foot in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced burning foot and nerve pain. On an unknown date, the outcome of the burning foot and nerve pain were unknown.   It was unknown if the reporter considered the burning foot and nerve pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine and about 10 days later he reported to the pharmacist that he was experiencing burning in feet while sleeping and nerve pain.  It was unknown if the events were ongoing or resolved. The reporter reported that the patient had it for several nights and only when sleeping. The reporter consented to follow up.
Patient states she had instant pain form flu shot given on 10/09/18. Patient complains of constant ache and musle pain. Patient feels nerve firings in upper arm and shoulder. Patient was seen by Dr on 10/31/2018. Patient called and alterted the pharmacy about this reaction on 01/09/2019.
Mom denied prev. illness. Mom, who is an RN, reports chills and fever within 1 hr of vaccine administration, swelling over left deltoid to left elbow and facial hive like rash. During the night results in scratching and fever. Temp of 103. On 11/3 became aware slight erythema swelling along jaw line and extending to neck, palpates left deltoid minimal swelling no erythema from at shoulder/elbow and unaware of any.
I began experiencing flu-like symptoms a few hours after receiving the vaccine. They were mild at first but by that evening I had chills, aches, a fever, and a headache. Around five p.m. the day of my vaccine (which was at 7 a.m.) I experienced sharp pain in my chest for about an hour unit it eventually dissipated. I didn't experience any chest pain after that. I woke up the next morning with all of the same other symptoms, except a rash was beginning to form on my body. It consisted of red dots all over my skin, specifically on my chest and neck but spread to cover my entire body over the next few days. It took about 7-10 days for the rash to completely disappear, and my flu-like symptoms lasted about five days.
We( pharmacy ) administered the first dose to the patient on 4-22-21.  pharmacy administered a second dose to the patient on 4-26-21. The patient then attempted to get a third dose at Pharmacy on 5-10-21. Patient said he does not recall getting the first dose or second dose. Pharmacy did not administer to him again after confirming with us we gave the first dose on 4-22-21.
About 2-3 minutes after receiving vaccine, patient became a little dizzy, wash visibly shaky, and face went pale. She was also hyperventilating a little. She mentioned her vision was starting to go dark around the edges. Patient was seated at this time. Her mother alerted us right away, we grabbed the emergency use bag and went out to monitor her.  Patient was responsive and we observed no swelling or trouble breathing. Patient mentioned she could breathe fine as well. Pharmacist had patient count her breathing (4 sec inhale, hold 4 seconds, 4 sec exhale, hold 4 sec), while instructing a coworker to grab a cold water. Patient was wearing a smart watch that showed her pulse, so pharmacist was keeping an eye on that as well (in the few minutes we were with her the highest pulse pharmacist saw was 78). We administered a dose of benadryl 50m to the patient at mother's request. Once the patient's breathing returned to normal (about 2-3 more minutes) the color came back to her face. Had patient wait about 15 more minutes, after symptoms resolved before letting them leave the store.
Information has been received from an office manager concerning a 7 year old hispanic female patient with no relevant medical history and no known allergies who on 21FEB1997 was vaccinated with a first dose of varicella virus vaccine live 0.5ml.On 21FEB1997, concomitant medication included a fourth dose of diptheria toxoid+pertussis vaccine+tetanus toxoid. On 06MAY2003 at 07:00, the patient was diagnosed with a moderate case of chickenpox also described as a moderate varicella rash. Medical attention was sought. The patient was given phenergen for itch/pain. ON 12MAY2003, the patient recovered. No further information is expected.
Patient is a 9 y/o male here with father with concern for vaccine reaction.  Father reports acute onset of fever along with redness, swelling, and pain of left upper arm at the site where patient received flu vaccine on 03/22/2021. Symptoms began on 03/23/2021 with Tmax of 101 degrees. Fever responded well to Tylenol. Parents have also given Benadryl to help with redness and swelling with some improvement,  pain has resolved.  Patient's last fever (Temperature 100 degrees) occurred in the morning on 03/24/2021, resolving with administration of Tylenol. When seen in clinic by me at 1 pm on 03/24/2021, fever had resolved.
Patient states that she woke up with hives all over her trunk, arms, and upper legs. Denies any other symptoms.
nasal and chest congestion; nasal and chest congestion; Severe dyspnea; tiredness; wheezing; coughing; headache; fever-like symptoms; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Mar2021 at 14:00 at age of 25-year-old at single dose for COVID-19 immunisation. Medical history included severe asthma, rhinitis, allergies to grapseed, beans and legumes. Concomitant medications included budesonide, fluticasone propionate (FLOVENT), omeprazole, tiotropium bromide (SPIRIVA), levosalbutamol hydrochloride (XOPENEX). There was no other vaccine in four weeks. Patient experienced severe dyspnea, nasal and chest congestion, tiredness, wheezing, coughing, headache, fever-like symptoms, injection site soreness; all on 20Mar2021 at 02:45 PM. The events were reported as resulting in doctor or other healthcare professional office/clinic visit and disability or permanent damage. There was unspecified treatment for the events. Patient didn't have COVID prior vaccination. Patient was not tested COVID post vaccination. Outcome of the events was not recovered.  Information on batch/lot number was requested.
12 year old client received Pfizer Pediatric dose.  Though, client was scheduled to receive Pfizer Pediatric dose, the client was ineligible to receive the dose and received it anyway.
None, client didn't even cry when flu shot was administered.  Follow up phone call to parent, 2 days later, client had no redness or swelling to his arm.
The patient received two Pfizer Bivalent injections.  One on 09/17/2022 and one on 12/17/2022
Information has been received from a physician concerning a 72 year old male with hypertension and no history of drug reactions or allergies who on 26-FEB-2008 was vaccinated with one dose ZOSTAVAX (Oka/Merck) (lot#: 65210/1079U) SQ. Concomitant therapy included lisinopril (manufacturer unknown), hydroxyzine, vitamin E, warfarin and simvastatin (manufacture unknown). On 23-APR-2008 the patient developed "a head to toe" rash, possible Shingles. The rash began on the back and anterior chest and continued to spread over the body including the scalp. The patient denied pain and fever at this time. On 09-JUN-2008 the patient was going to see the physician. The patient was started on acyclovir and steroids by another physician. Three months later (on approximately July 2008) test results suggested the patient had vasculitis. Subsequently the patient recovered. Additional information is not expected.
13 patients received a 0,5 ml booster dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 10-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.). On 10-Nov-2021, ACCIDENTAL OVERDOSE (13 patients received a 0,5 ml booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Triggered being positive for Hashimoto antibodies; elevated TSH; Genital Herpes outbreak; severe breakout eczema around mouth; Wheezing; coughing; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 14:30 (at the age of 58years) a as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 17Jan2021 13:30 (Batch/Lot Number: 3247) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced triggered being positive for Hashimoto antibodies, elevated TSH (thyroid stimulating hormone), Genital Herpes outbreak, severe breakout eczema around mouth, wheezing, and coughing. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Thyroid medication and Valacyclovir. Covid test post vaccination: Nasal Swab on 08Mar2021, result: Negative. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Information has been received from a physician concerning a male (age unknown), who in approximately November 2006, was vaccinated with a dose of PNEUMOVAX.  After receiving the vaccination the patient's arm was extremely painful and swelled at injection site more then usual and the redness went all the way down his arm.  At the time of the report, the patient had recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Since 14-FEB-2017 to 13-JUN-2017, the patients were vaccinated with an unspecified number of improperly stored ZOSTAVAX injection (dose was no reported, lot # and expiration date were unknown by the reporter) diluted with sterile diluent (lot # and expiration date were unknown by the reporter). Administered doses of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. The sterile diluent had no excursion. There were no adverse effects reported. Additional information has been requested.
Erythema & swelling of arm with pain 3.0 x 5.5 area of large confluent vesicles at site treated with DIPROLENE ointment, VALTREX 1 gm tid x 1 wk, area bandaged.
One day after receiving first dose (9Apr2021), patient's heart would race for about 10 minutes.; patient had difficulty breathing and had to sit down to rest; This is a spontaneous report from a contactable consumer (Pfizer colleague) and a non-contactable consumer. A 87-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 both as a single dose at the age of 87-year-old for COVID-19 immunisation. Medical history included heart conditions (not specified) and had pacemaker (cardiac pacemaker insertion). Concomitant medications included warfarin sodium (COUMADIN) and blood pressure medication(unspecified), all from unknown dates and for unknown indications. It was unknown whether the patient had any allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 09Apr2021 one day after receiving first dose, patient's heart would race for about 10 minutes. During this time, patient had difficulty breathing and had to sit down to rest. The reporter noted that the patient had a pacemaker device and was on coumadin and BP medications. The device would sizzle and then symptoms would settle. These episodes had occurred about 4 times a day since first dose. The reporter noted that the same episodes was occurred after the second dose, but increased to 6 times a day. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events heart race and difficulty breathing were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving vax pt started screaming and crying uncontrollably. This lasted for 5 days. He also ran a temperature of 100-102. Tylenol was given.
Patient had heart palpitations and lightheadedness 15 minutes after first Covid 19 vaccine, episode lasted 30 minutes. She was monitored for 30 minutes in the supine position. Only reported HA and faintness that lasted a few minutes. Denied heart palpitations, SOA, N/V, etc. Released to leave after 30 minutes.
No additional AE; PROQUAD administered to 14-year-old; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 07-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliters (ml) by subcutaneous route as prophylaxis (lot number U029324 which has been verified to be valid, expiration date reported and validated as 19-MAR-2023) (anatomical site of injection was not reported) (product administered to patient of inappropriate age). No additional adverse events were reported in the patient.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 029K20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), OLANZAPINE, MELATONIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired). At the time of the report, DIZZINESS (Dizziness), RASH (Very bad rash in his back and chest) and FATIGUE (Feeling Tired) outcome was unknown.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Document received is mostly illegible. Patient demographics updated. On 29-Jul-2021: Non Significant follow up On 02-Aug-2021: Follow-up received : No new information
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Paoriatic arthritis" (unspecified if ongoing), notes: Paoriatic arthritis; "joint replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of COVID-19 Paxlovid from 27Dec2022 to 01Jan2023 for COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
18 hrs p/immunization fever 102.4, extreme irritability, chills; APAP given 6PM 12NOV91 & 10PM 12NOV91 & 10AM 13NOV91;