chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting on the day after the vaccine 2nd dose, I got a very bad severe migraine like  headache right away.   I had extreme sensitivity to light and had to lay down.  My left eye was getting blurry and I was feeling severe pressure and pain.  I could not walk or stand up and felt very heavy.  I had tinnitus (ringing in both ears) and painful  inner ear pressure that exacerbated my headaches.  The next day, my symptoms were getting worse and now I had pain in my neck and spine. My joints in my spine and neck felt swollen,inflamed and was very painful.  I called my PCP and they recommended Tylenol and to  go to Urgent Care.  I was prescribed Prednisone and muscle relaxer.  The medications did not help.  My PCP then advised to go to the ER.  They did blood work, 2 spinal taps, MRI and CAT scan.  I was in the hospital for 1 night.  Everything came back normal.  I was discharge and instructed to let the vaccine run its course.   I am still suffering with nausea, headaches, pain in neck and spine with no improvements. It has affected my quality of life and I am still out of work.  I am unable to do simple daily tasks.
Information has been received from a 59 year old female consumer who on 11-NOV-2010 or 12-NOV-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (Lot # not reported). There was no concomitant medication. The consumer reported that on 11-NOV-2010 or 12-NOV-2010 after receiving the first dose, her upper arm was a little sore near the injection site that lasted for 2 days. The patient had recovered (approximately on 13-NOV-2010). There were not laboratories performed. The patient did not seek medical attention. Additional information has been requested.
pt recvd vax 11AM & w/in 5 mins began screaming, high pitched, inconsolable; cont throughout day & didn't end until 9PM; pt slept all noc but cried & whined in sleep; resolved by next AM; t100, vomited 2 times; MD called & told mom nl;
Pain in arm, full body muscle and joint aches, fever several dats later, immediate rash now spreading across body,severe chills
fever, nausea; 4DEC93 tired, h/a relieved by APAP; 5DEC93 tired, h/a, muscle aches;
Pregnant patient received two Tdap vaccines during her pregnancy.  08/12/20 and 12/07/20. Pt delivered infant on 02/22/21.
Member presented to medical for bandage change and noted a few inadvertent inoculations on left deltoid. Member re-educated on proper site care and bandage change and instructed to return if symptoms worsen.
Could not sleep night the shot; Had chills; No appetite; could not have a bowel movement; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 14:00 (Batch/Lot Number: EWG200) at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]); atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN) colecalciferol (VITAMIN D). No known allergies. The patient not had other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient could not sleep night the shot. He had chills, chills stopped after 16 hours, No appetite, could not have a bowel movement on 23Feb2021 at 02:00 PM. Outcome of chills was recovered on 24Feb2021 and outcome of other events was recovered on an unspecified date of 2021.
Patient called 3/14/07 reporting child had reaction to immunization complained of edema in right deltoid which started day of administration 3/12/07. Records show Menactra administration right deltoid. Each day edema at site has progressed, area size of silver dollar today. Parent reports pt complained of feeling faint after immunizations. Denies fainting episode. No fever, rash. Pat does complain of pain at sites. Cool compress to site on 3/14/07. No problems with mobility. Tylenol administered for pain. Mother instructed to see MD.
On 09/15/2022 I received my Covid-19 vaccine. On 01/03/2023 I started flu like symptoms, extremely tired, cough and congestion.  I took Covid-19 home test and was positive for Covid. After reaching out to the doctor I was prescribed Robitussin Codeine and steroids. Symptoms still ongoing.
2nd booster shot for covid. Hardness and swelling at injection site, discomfort/aches/tingling down left side of body, swollen lymph node under arm and radiating down to areola of left breast. Swelling of left breast. Aches in left side of chest area.
Painful to move neck; Muscle stiffness; Pain on injection side; Diarrhea; Swollen lymph nodes on neck and shoulder area; Being sore; A spontaneous report was received from a man calling on behalf of his wife who is a 38 year old, female consumer who received Moderna's COVID-19 vaccine and experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) for prophylaxis of COVID-19 infection.   On 30 Dec 2020, within minutes of receiving the vaccine, the patient experienced swollen lymph nodes on neck and shoulder area, painful on the injection side, diarrhea, muscle stiffness and being sore. Treatments for the events is unknown. On 07 Jan 2021, the swollen area is pretty big and painful to move the neck. Treatment is Unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, swollen lymph nodes on neck and shoulder area, painful on the injection side, muscle stiffness and being sore is Unknown. Diarrhea was light at the beginning first few days and then got bad for a couple of days and fully recovered on the 5th Jan 2020.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Broke out with red spots.  Continued to get worse so went to my Dermatologist, had a biopsy and the results were Lichen Planus.  I was prescribed a steroid cream twice but symptoms are getting worse.
pt recvd vax; pt devel hives w/ in 2 hrs of vax; pt exp'd moderate itching; tx benadryl;
This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On 12th April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. The reporter considered the shingles to be possibly related to SHINGRIX. Additional information was received as follows: The initial report was reported by the physician, however, during the phone call/report, the physician put medical assistant on the phone to provide further details about the event. The reporters had limited information on the pharmacy that administered the vaccine to the patient. The patient received the vaccine 2 weeks ago, physician stated that the patient presented to the office on the day of reporting with shingles. The patient visited emergency room. The reporters did not have lot information. No other information available at the time of the call.
Pt had a rash appear, 8/31/00 with fever temperature 102 yesterday came to office with whelps all over body. Vital signs stable. Benadryl and epinephrine, redness decreased and rash lessened
This spontaneous report was received from a parent consumer refers to a 39 year old female patient. ON an unspecified in 1998 (reported as 15 years ago), the patient was vaccinated with VARIVAX for prevention of chickenpox (lot number, dose, route not reported). It was reported that on an unspecified date in 2009 (reported as on approximately 4 years), her daughter tested, via blood work, as positive for varicella. Her daughter no longer had immunity to VARIVAX. Reporter was also unsure as to if her daughter ever received 2 doses of VARIVAX. The patient did not seek medical attention. The outcome of titers came back equivocal was unknown. The event was unknown related to VARIVAX. Additional information is not expected.
Covid bivalent vaccine was given as the second dose in the series.  Also, patient was vaccinated at 20 days after administration of the first dose.  No adverse effects reported.
POSITIVE SIDE AFFECTS (GLUTEN ISSUE AND VITILIGO RASH AND PIGMENT IN SKIN WAS CLEAR); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included rash, and vitiligo, and concurrent conditions included gluten issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced positive side affects (gluten issue and vitiligo rash and pigment in skin was clear). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive side affects (gluten issue and vitiligo rash and pigment in skin was clear) was not reported. This report was non-serious.
patches quilt like on both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (patches quilt like on both arms) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (patches quilt like on both arms). At the time of the report, RASH (patches quilt like on both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment was taken by the patient for the event.
Neurological, tremors, twitches, cognitive, brain fog, insomnia, anxiety, heart palpitations, weight loss, gi problems, headaches
sore arm; This is a spontaneous report from a contactable physician, based on information received  (manufacturer control number: EC-2021-087939).  A female patient of unspecified age received bnt162b2 first dose on 15Feb2021 at single dose for COVID-19 immunisation. Medical history included C55 Malignant neoplasm of the uterus (on Keytruda). Concomitant medications included lenvatinib mesylate (LENVIMA) 10 mg from 11Feb2021 to 12Feb2021 for Endometrial cancer (action taken was Temporarily Withdrawn). Patient reported she received a COVID shot on 15Feb2021, and she has a sore arm on 15Feb2021. Patient will get the second dose in Mar2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about batch/lot number cannot be obtained.
getting very bad leg pain like throbbing ,aching ,burning; getting very bad leg pain like throbbing ,aching; feeling you know like especially around my knee and the front of my thighs; there were like twitching also; This is a spontaneous report received from a contactable consumer (patient). This 72-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9263) via an unspecified route of administration on 25Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included a bad allergy to dust and her immune system was "kind of hyperactive." Concomitant medications were not reported. In Feb2021, when the patient took dose 1 of BNT162B2 she felt fine but the 11 hours later started getting very bad leg pain like throbbing, aching, burning. There was like twitching also that lasted very badly until the end of the next day and then it sort of went away. For almost three and a half weeks there was this feeling especially around her knee and the front of her thighs. The outcomes of bad leg pain, throbbing, aching, burning, twitching, and feeling around her knee and front of her thighs were recovered. It was also reported that the patient received dose 2 on 25Mar2021.   No follow-up attempts are needed. No further information is expected
patient was given pediarix with pentacel at the same time; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who PEDIARIX and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that patient was given Pediarix with Pentacel at the same time (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On 02-Jan-2020, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ054AA and expiry date: 27-Oct-2020 via intramuscular route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness/firm round swelling at injection site in left arm about an hour after appointment. Ache in arm started about an hour later. Diarrhea about 2-3 hours later, however, I have chronic gastrointestinal issues exacerbated by anxiety and this may not be an adverse reaction.  Day 2: distracting/inconvenient ache in arm, redness/swelling at injection site. Slightly itchy. Slight headache.  Day 3:  distractingly itchy. Only slight ache. Redness/swelling reduced slightly.  Slight headache.  Day 4: persistent headache, reduced but not gone by the end of the day. No ache. Itchiness slightly reduced. Redness/swelling slightly reduced.
I could not move my arm. It was FROZEN. My shoulder SWELLED UP INCREDIBLY BAD,........  I had the shot on 05-22-2018 and tried my best to overcome the PAIN AND SWELLING, sweating at night, shakes, temperature, loss of appetite, inability to move my shoulder. It was "TOTALLY LOCKED" and I could not take the pain anymore so I went to Urgent Care for help with the pain. I got a shot of TORADOL in my right hip and then a shot of steroids in my left hip. I got Rx a bottle of TORADOL pain pills (30) and a MEDROL DOSE PACK. All this was done on 05-31-2018 around 5 p.m. Side effects started on 5-22-2018 and I could not take the pain and finally gave up and went to the Urgent Care Clinic on 5-31-2018,........and my side effects finally resided on 6-10-2018.  My side effects lasted from 5-22-2018 to 6-10-2018.
6Jul91 pt had swelling & pain lt wrist/rt ankle/rt middle finger,adenitis;ANA & RF-neg;sz subsided on 24oct91 & recurred intermittently on 21sep91;6oct92 &  nov92 hep B vax followed by joint pain in hand;
pt recvd vax & 6 days later pt devel 8.10cm area of erythema & localized edema as well as soreness of the lt upper arm below the inject site;
4 x 2 3/4 inches area of warmth, redness and tender (L) thigh around injection site. KEFLEX (250/5) 2 ml PO TID x 10 days.
Evening after COVID booster - Aggressive behavior, unusual behavior, memory loss, tremor in right hand worsened, brain fog. Next day after COVID booster - Brain fog, Fell and hit head, ER visit due to fall, Tremors worsening Two days later - Patient and wife report to the pharmacy to give summary of events from weekend. The patient continued to have tremors in right hand, memory loss, brain fog, and did not feel his normal self.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expiration Date for the lot 070H21A was reported as 07-Apr-2021, no. of doses/vial were 173 doses. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non-significant information.
High fever, chills, headache, body aches. Began about 12 hours after vaccination, peaking at 16 hours and subsiding the next day.
Information has been received from a registered nurse concerning a 17 year old female who was 18 weeks pregnant and was vaccinated with her first dose of GARDASIL (lot 653978/0955F) on 29-Nov-2006. There was no concomitant medication. In March 2007, the patient experienced an abortion. The nurse believes that the patient terminated the pregnancy for reasons other than the vaccine. The first dose of the vaccine was given at her pediatrician's office. Subsequently the patient experienced an inappropriate schedule of the vaccine when she received the 2nd dose on 24-Apr-2007. Upon internal review, abortion was considered to be an other important medical event. Additional information has been requested.
Approximately, 15 minutes after receiving Td- Pt's chest became completely covered with raised rash with intense itching. Approximately 5 minutes later she complain of difficulty breathing.
Noticed a 2-3 inch hard, red itchy patch near injection site. Started on Day 8 post-vaccination. Used hydrocortisone 2.5% cream once. Resolving on Day 11 post-vaccination.
Mother states she noticed reddening at the site of injection with in hours after injection. Blisters noted later. Left arm - (+) irregular shaped erythema around the arm with multiple blisters with area of 1/2" diameter, imbilicated bumpy red blister with skin peeling.
Bright red rash starting to turn purple; raised, angry rash raised, angry rash all overback, chest, abdomen, neck and face.; raised, angry rash all over back, chest, abdomen, neck and face; Swollen right side face including cheek, eye and ear; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old adult non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 AM (at the age 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Lyme disease, PCOS, asthma, rosacea, Hashimotos thyroiditis, diverticulosis, celiac and IBS. Multiple food and drug allergies reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021 at 05:00 AM, patient experienced raised, angry rash all over back, chest, abdomen, neck and face. Rash was bilateral and worse on right side. Patient also experienced Swollen right side face including cheek, eye and ear and bright red rash started to turn purple as the day passed. The patient did not receive any treatment for the events. The clinical outcome of rash all over back, chest, abdomen, neck and face, swollen face and red rash was recovering.   Information about lot/batch number cannot be obtained. No further information is expected
Day 1-2: sore arm Then nothing until day 9- when my upper right arm became red, itchy, swollen.
Patient received vaccination seemed okay went to get a drink of water.  Sat down in waiting room and said she was going to pass out.  I ran out she passed out for 30 seconds.  She was completely out I shook her arm called her name several times.  She came to and was very clammy and sweating.  Her skin went pale.  She vomited.  I laid her down on the floor.
Muscle or body aches  Headache  Sore throat  Diarrhea
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/8/2021 for unknown duration.
Small pimples on the legs; Itching; Feeling uncomfortable; he has some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder; This is a spontaneous report from a contactable consumer (patient himself). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0164, Expiry date, NDC number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Age at vaccination 71-years-old) as dose 1, single for covid-19 immunisation. Medical history included thyroid disorder, prostate cancer from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; dutasteride, tamsulosin hydrochloride (ASOFLON DUO) taken for prostate cancer, start and stop date were not reported. The patient got the first Pfizer Covid vaccine on 16Apr2021, the next one must be 7May2021, but he got the first vaccine, it was 8 days after and on 24Apr2021 he had some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder, it was itching a lot, small pimples on the legs, feeling uncomfortable, stated a doctor gave him some pills and it was for some allergy that he may have. After he took the medication went for 3 days and the rash is not going way. Worried about getting the next vaccine, seeking guidance and stated he also was eating fish this day as well, but has never had any reaction. The medications the doctor gave him for the rash are prednisone 5mg one time a day for 3 days, no refills. Product is in a pharmacy vial, NDC, Lot, and expiration date are unknown. For the itchings the doctor gave him loratadine. States this helped and the itching is better, but the rash is still there. Stated he also took Motrin for the itching. Therapeutic measures were taken for the events. The patient received treatment for the events. The clinical outcome for the events experienced he has some rash on his arms and parts of his stomach and his back, some on his hands, legs and shoulder was not recovered, itching was recovering, and rest other events was unknown.  No follow-up attempts are needed. No further information is expected.