chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE THROAT; EXTREME MUSCLE ACHE; FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 50-year-old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and hysterectomy, and concurrent conditions included fibromyalgia, and non-smoker, and other pre-existing medical conditions included no known allergies.  The patient was previously treated with Magnesium, Cimicifuga racemosa rhizome/cimicifuga racemosa root, Fluoxetine, Topiramate, and Estradiol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced extreme muscle ache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-APR-2021, and was recovering from extreme muscle ache, fatigue, sore throat, and headache. This report was non-serious.
Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.
Headache, muscle ache, body ache, some shortness of breath when talking and feeling very tired.
Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beginning day of vaccination
Severe itching, whole body lasting 6 months now tapering off at 10 months.  Emphasise SEVERE!  2 unusual blood clots almost immediately after insertion of midline in both arms. Never had blood clots after many midline and pic lines inserted over last 30 years.
Pt presented to ED with concern for an allergic reaction after she had the Covid vaccination.  The patient had a severe Covid infection with prolonged ICU stay and intubation in December.  She states that she has been trying to get back to walking and exercise.  She is followed by pulmonology due to shortness of breath.  She has not yet had an oxygen requirement.  The patient states she had the Covid vaccine today and shortly after began having a sense of swelling around her eyes itching on her back and down her arms as well as shortness of breath.  She states that she felt she had a vagal episode immediately after the shot and then the other symptoms started.  The patient denies sense of swelling of her throat tongue or lips.  The patient states that with her asthma she does not typically wheeze.   pt treated with 2 doses of Benadryl, Ativan.
breathing issues bad enough to use my inhaler 3 times in 24hrs, fatigue, headaches and pain and hot at injection site: motrin, rest and ice
Information has been received from a consumer referring to her 12 month old grandson. There were no pertinent medical history or drug reactions/allergies. On 03-NOV-2016, the patient was vaccinated with PROQUAD (dose, lot number, route not provided) and VARIVAX (dose, lot number, route not provided). The patient did not seek medical attention and there was no treatment given for the event. The outcome of the event was unknown. There was no product quality issue (PQC) involved. Additional information has been requested.
Approx. 45 minutes after receiving 1st shot of Novavax, I began to feel a tightening in my throat as if mucus or phlegm was stuck in my throat, but when I tried to clear my  throat no mucus or phlegm came up.  I started to feel alittle panicky so I took 2 Benadryl, 25 mg liquid capsules.  After approx. 20 minutes had passed, the throat tightening eased.  I had received the 1st Moderna shot last Aug-2021 and had a severe reaction.  I had to be taken to the emergency room with trouble breathing.  I cannot take Mrna vaccines, or J&J, and have been waiting so long for the Novavax vaccine.  I want to receive the 2nd Novavax shot, but am afraid I might have a more severe reaction of throat tightening.  I am going to contact my doctor to ask what I should do.
Exactly one week after my first dose, a red itchy rash appeared at the site injection on my left arm.  The rash grew larger over the next 3 days and then eventually faded.  Also had some pain in my right calf muscle near some varicose veins.
pt recv vax MAR97 & JUN97 pt exp diffuse hair loss in clumps;
Chills, fever, body aches started at 2:30 AM (woke me up). I shivered for maybe 30 minutes before taking a hot bath. This helped with chills, but body aches got worse for the next 12 hours or so. My fever reached 100.7 F.  All adverse effects ended within 24 hours of onset.
Patient received influenza vaccine on 11/20/13 at a flu clinic for employees staffed by nurses from another facility. Patient called facility the next morning to report that she woke up with an "itchy rash" on her chest and face. She denied any difficulty breathing or shortness of breath. Patient was encouraged to take a Benadryl and contact her PCP. The Lead RN contacted the patient x 2 on 11/21/13. Pt. reported that she was at work and that the symptoms had not worsened and she had not taken any Benadryl. She had contacted her PCP and was awaiting a return phone call. She continued to deny shortness of breath/difficulty breathing and no emergent care was deemed to be necessary.
This case was reported by a consumer (subject's mother) and described the occurrence of unusual crying in a 4-month-old female subject who was vaccinated with DTP vaccine (A or W not known) (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included umbilical cord infection. Relevant medical history included an infection of the umbilical cord when the subject was 10 days old. The infection was treated with an antibiotic; however, the subject's mother does not know the name of the antibiotic. Concurrent vaccination included poliomyelitis vaccine (described as "OPVIPV1"), unspecified; manufacturer unspecified; unknown given on 3 March 1989. Per the subject's mother, there were no concomitant medications at the time of vaccination. There were no adverse events to previous vaccinations. On 3 March 1989 the subject received 1st dose of DTP vaccine (unknown details). The DTP vaccine was described as "DTP1 vaccine." The mother was unsure of the manufacturer of the DTP1 vaccine but the other siblings received "DTP1 vaccine" from Conna. On 3 March 1989, less than one day after vaccination with DTP vaccine (described as "after the shot"), the subject experienced unusual crying (described as a "high pitch whine") and discomfort (described as "uncomfortable"). The mother described the events as "an allergic reaction." The subject was treated with TYLENOL and, per the mother, the "symptoms resolved shortly after that." At the time of reporting the events were resolved. Per the mother of the subject, the DTP vaccine series was discontinued. Follow up was received from the consumer (subject's mother) on 25 October 2013. Per the mother, the subject decided to receive a Tdap vaccine and "had no side effect or complication."
Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever.
Patient developed a rash 4 days after recieving the Zoster vaccine.  She described it as itchy, red bumps on her upper arm. She also developed a few blisters around this area.  This rash then spread to her forearm.  I recommended she use Benedryl cream to help with the itching.  She later informed me she had used the Benedryl cream as well as Eucerin cream which provided releif from the pruritis.  She stated that the rash resolved after 6 days.
This spontaneous report was received from a 65 year old female patient regarding herself via market research agency. No medical history was reported. On an unknown date in August 2012, the patient was vaccinated with a dose of ZOSTAVAX. No concomitant mediations were reported. On an unknown date in September 2012, the patient started to break out 1 week ago after vaccination with bumps on lower back which was confirmed by HCP as shingles. Patient took medications provided by the doctor plus BENADRYL cream. No diagnostic tests were performed. The outcome of shingles was reported as recovered on an unknown date October 2012(3 weeks duration). The causality was not reported. Additional information has been requested.
Headache, Myalgia, Photophobia, fatigue Narrative: Onset about 8 hours after receiveing vaccine. 24 after vaccine, H/A is much improved.
Patient was supposed to be receiving a flu shot but Pfizer Covid-19 was inadvertently grabbed and given to patient Patient is currently on way for treatment
Day 8 post vaccination patient has right sided supraclavicular and right axillary lymphadenopathy.
As with my initial covid vaccination, one hour after this booster, my face turned bright red.  I had stayed at the clinic with the EMTs due to the prior reaction.  The RN told me to begin Benadryl.  I took it and after 24 hours seemed to subside but when I stopped the Benadryl it came back, so I took a second day.
This spontaneous report was received from a registered nurse who refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The reporter stated that on 18-FEB-2016 or 19-FEB-2016, the unspecified patients were inadvertently administered improperly stored doses of VARIVAX (Merck) (lot # L028276, expiration date: 28-JUL-2017, dose and route not reported). No concomitant medication was reported. The storage temperature was -13 C degrees, the time frame was 10 min and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse via field representative and refers to a patient of unspecified age. The patient's medical history included unspecified breakouts and no concurrent condition. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dosing information not reported). Concomitant medication was not reported. The reporter stated that the patient had experienced "several" unspecified "breakouts" before and after receiving ZOSTAVAX. The patient was hospitalized at an unspecified hospital for an unspecified "breakout" on an unspecified date after receiving ZOSTAVAX. The patient had recovered from unspecified "breakouts" (characterized as adverse event). The reporter did not provide the causality assessment between the event and ZOSTAVAX. The event "unspecified "breakouts" (characterized as adverse event)" was considered serious due to hospitalization. Additional information has been requested.
Headache, Rash, TIREDNESS Narrative: EMPLOYEE PHONED PCP AND WAS TOLD TO "WAIT IT OUT"
My right upper arm, about four inches in diameter around the injection site, became swollen, hot, tender and incredibly itchy. I attempted to control with oral benadryl for 24 hours, the redness grew and the itchiness remained intense. Topical benadryl with cold packs seemed to help temporarily. This lasted approximately 4 days. At that time the redness and swelling faded, giving way to bruising, and the itching has become less intense but still requires some topical benadryl at least twice per day. No blisters or open sores.
Extreme tiredness next day, sore arm. Redness and swelling at injection site. Same today 3rd day.
Myalgia, Fever, SkinRash & NauseaVomiting Narrative:
Rash on the same arm the vaccine was administered (left arm) that was raised red bumps from the elbow to the hand; Rash on the same arm the vaccine was administered (left arm) that was raised red bumps from the elbow to the hand; This spontaneous case was received on 29-Sep-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-02995) and concerned a 51-year-old, female patient.   The patient's concurrent conditions included allergy to Compazine (prochlorperazine edisylate) and allergy to penicillin. The patient's concomitant medication included Bupropion (bupropion hydrochloride), Dexilant (dexlansoprazole), Nasonex (mometasone furoate) and Shingrix (varicella zoster vaccine rgE (CHO)) administered on an unspecified date in 2021 ('couple of weeks before' as reported), all used for an unreported indication.  On 28-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left arm, dose and route of administration: not reported) to prevent influenza. The batch number reported was P100354284, expiry date: 14-Jun-2022.   On the same day, two hours after receiving Afluria Quadrivalent, the patient experienced rash on the same arm the vaccine was administered (left arm). The rash was raised red bumps from the elbow to the hand.  At the time of initial report on 29-Sep-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment to Afluria Quadrivalent.   This case was assessed as non-serious.  Company comment: Events of 'raised rash' and 'red rash' are assessed as related to Afluria Quadrivalent.; Sender's Comments: Events of 'raised rash' and 'red rash' are assessed as related to Afluria Quadrivalent.
Injection site is red; Injection site swollen; Injection site painful; This case was reported by a consumer and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional case details were reported as follows: It was reported that the patient received Shingrix and her injection site was still red, Swollen and painful.
Information has been received from a nurse practitioner concerning a female who on 03-MAY-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 03-MAY-2007, the injection site became red and swollen and the patient experienced nausea. The patient sought unspecified medical attention. At the time of this report, the patient was not recovered. Additional information has been requested.
Significant dry mouth and oral sores from dry mouth- continuous and has not gone away. So bad that I got tested for Sjogren's which was negative
Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-SEP-2022 and administered to patient on 12-JAN-2023).    No concomitant medication was reported.  The BUD date was reported as 01-OCT-2022. Date the vial was initially stored in the refrigerator on 01-Sep-2022. The vial did not undergo any temperature excursions.  Dosage text reported as Unknown. No treatment information was reported.
mom reports that 10 days p/vax devel a t103.4 & mild nasal rhinitis-mom gave APAP but fever reoccurred approx 4hrs later;pt devel a sz that mom described as a gazing not responding to any verbal stimuli, shaking & stiff body tone;to ER
This occurred with the booster shot.  Dizziness when I woke up the next morning to go to work at 6am.  It was not as bad as vertigo as it was less severe movement as I could walk around slowly, but the room was moving around and starting to make me nauseous.  I laid down and closed my eyes and it stopped, but when I got up again it reoccurred right away.  I took the day off as a sick day.  I went back to bed and stayed in bed dozing until 9:30 am.  At that point the dizziness had stopped.  I just had a dull headache for the rest of the day until around 7pm.  After that I was fine.  The shot area was not tender or sore as it was for the previous two shots.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: within 15 minutes of second dose administration patient began experiencing tingling in the mouth and tongue. 23 minutes after hands began to tingle and benadryl was given. After waiting 30 minutes patient still felt tingling in mouth, tongue, and hands but would go home and rest.
Inconsolable crying lasting 2 days. Fever of 104*F for 2 days. Lethargic. Listless.
heart rate elevated really bad; This is a spontaneous report from a contactable consumer(patient). A 33-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, in right arm on 12Apr2021 (at the age of 33-years-old), at a single dose for COVID-19 immunization. The patient did not have any medical history or concomitant medications. The patient's heart rate elevated really bad 3 hours after vaccination on 12Apr2021. The event resulted in emergency room visit on 14Apr2021. The outcome of the event was recovered after a week in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Almost exactly 1 week after getting the first Moderna shot, I woke up and had hives on my lower arms and hands. The next day it spread to my feet, ankles and knees. The next day it was on my thighs, arm pits and groin. The fourth and fifth days it didnt seem to spread anymore, but it was quite uncomfortable. Avoided alcohol and sunlight/heat as much as possible, but I do work in a hot warehouse. Very itchy. One spot on my foot "broke open" and was stuck on my sock, but soaking in luke-warm/cold oatmeal bath helped a lot overall. I did not start taking Benadryl until the third day, I believe. Benadryl seemed to really help after a couple of days. I am a smoker, but no respiratory problems. It is now 13 days after the dose and they are still lingering, but just as a red rash/spots. I have had an abnormally large amount of stress the past few weeks, as I am sure that has been adding to it. From what I've seen online, it is almost like shingles. I do not have a PCP in Indianapolis, so I have not seen anyone about it. The strangest part is that they are almost a mirror image on my body. Every one of the spots is practically identical on either side.
left leg and foot swelling and edema for several days, still persisting, never happened before. presumed blood clot.
feeling under the weather; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling under the weather) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feeling under the weather). At the time of the report, VACCINATION COMPLICATION (feeling under the weather) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 25-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 15-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
dizziness; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 19May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 19May2021. Two days later (21May2021) and since then, he has presented dizziness. This dizziness produces a feeling of instability. He has used medications for the dizziness. At times, the symptoms improve but always return. He wanted to know if he should receive the second dose of COVID-19. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
This case was reported by a physician via call center representative and described the occurrence of induration in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced induration. On an unknown date, the outcome of the induration was unknown. It was unknown if reporter considered the induration to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. As per the physician, he had a patient who got BEXSERO and experienced induration, larger than what was described in the package insert. The physician refused to provide more information.