chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SO OFTEN LEFT SIDE  NUMBNESS IN HER LEG AS IF HER  LEG WANTED TO GO TO SLEEP WHICH  LASTED GOOD 15 MIN AND RETURNED  SAME THING IN THE EVENING; VERY BAD STRONG HEADACHE; THE SMALL HIVES; HARD TIME TO SLEEP; ITCH IN BACK, ARM, AND LEGS; SCRATCHING THE BUMPS; HEAVINESS; TINGLING FEELING TRAVELING FROM HAND UP TO ARM; SWELLING IN  ARM  IN THE INJECTION SITE; PAIN IN  ARM IN THE  INJECTION SITE; COLD TRAVELING FROM THE LEFT HAND UP  LIKE NUMBNESS, GOING BACK AND FORTH; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-alcoholic, non-smoker, and hypertension, and other pre-existing medical conditions included: patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced cold traveling from the left hand up like numbness, going back and forth. On 02-APR-2021, the patient experienced heaviness. On 02-APR-2021, the patient experienced tingling feeling traveling from hand up to arm. On 02-APR-2021, the patient experienced swelling in arm in the injection site. On 02-APR-2021, the patient experienced pain in arm in the injection site. On 03-APR-2021, the patient experienced hard time to sleep. On 03-APR-2021, the patient experienced itch in back, arm, and legs. On 03-APR-2021, the patient experienced scratching the bumps. On 03-APR-2021, the patient experienced the small hives. On 08-APR-2021, the patient experienced very bad strong headache. On 09-APR-2021, the patient experienced so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold traveling from the left hand up like numbness, going back and forth, heaviness, and tingling feeling traveling from hand up to arm, itch in back, arm, and legs on 04-MAY-2021, and so often left side numbness in her leg as if her leg wanted to go to sleep which lasted good 15 min and returned same thing in the evening on 11-APR-2021, and the outcome of swelling in arm in the injection site, hard time to sleep, scratching the bumps, very bad strong headache, pain in arm in the injection site and the small hives was not reported. This report was non-serious.
pt recv vax 25MAR97 & 28MAR97 pt devel a few papules on skin, which were not thought to be a varicella vaccine rxn;
consumer was given an expired dose of Adacel on 11Dec2019, no AE; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 61 years old female patient who received 0.25 ml to 2 ml dose an expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U5793AA and expiry date:01-Nov-2019) via unknown route in unknown administration site, on 11-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RUBELLA VACCINE (RUBELLA) for Immunisation; MUMPS VACCINE (MUMPS VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used. It was reported that consumer was given an expired dose of Adacel on 11Dec2019 in error.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
I received the shot on Wed, 3/31 at about 7:40pm.  After I left the pharmacy I realized that I was feeling uneasy,  thought it was anxiety, nothing helped to ease it. I  realized later that I had faster heartbeat than normal, tried to breathe which didn?t help. I was finally able to fall asleep after 1am and woke up early next day and was very tired and still not right. I work at home so I spent the evening relaxing. On Friday morning I went to urgent care. They did EKG , purse was 130. They consulted a cardiologist in the same practice and said EKG otherwise looked normal (they compared it to previous ones).  I went back home and spent the rest of the day lying down,  realized later in the evening that my pulse went somewhat back to normal and I felt better.  So it took 48 hrs  overall.
still sore left arm; body was clammy; headache; chills; nausea; vomiting, threw up once; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still sore left arm), COLD SWEAT (body was clammy), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A12A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Hypertension.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COLD SWEAT (body was clammy), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting, threw up once) and PYREXIA (fever). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (still sore left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at a dose of UNK dosage form. On 11-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (still sore left arm), COLD SWEAT (body was clammy), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting, threw up once) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications include blood pressure medicines.
*ADMINISTRATION ERROR*  49 Y/O PATIENT RECEIVES SECOND BOOSTER DOSE (MODERNA) BEFORE RECOMMENDED AGE.
On day p/vax w/DTP/HIB pt devel inconsolable crying x 2-3 hrs, weird high-pitched, & periodic tensing, twitching movements of extremities as if was in pain, t102;
Right shoulder began to hurt after the injection and hasn't really calmed down, unable to lay on it and I will need to send her to PT and ortho.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 13-JAN-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outsides of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
12 days after 2nd Moderna dose, woke up around 2:15 am to a painful, sore, burning lump on the base of my rightside neck, clavicle area.  Scheduled apt with PCP same day.  Also had just began three treatments of a new product, Olay Peptide 24.  Not sure if swollen lymphnode due to vaccine or new product.  PCP instructed to monitor and take ibuprofen for pain/inflamation.  When receiving both doses of the moderna vaccine, I experienced right neck stiffness within 2 hours of vaccination that lasted approximately 36 hours each time.  To note previous medical history, I had Bells Palsy at the age of 12 years and Shingles around age 45, both impacting my right side.
Pt reported to have fever over 104 the evening following shot; Started w/vomiting the following morning; Continued w/fever; Seen by MD dx Strep throat-PCN failed to resolve fever; pt hospitalized;
Client got hives on her arm around the injection site about 24 hours after the vaccine was given
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Certified Medical Assistant and refers to a 12 month old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 29-SEP-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, frequency, route of administration, were not reported) lot # T032317, expiration date 22-SEP-2022 for prophylaxis. No additional sdverse event details available.  On an unknown date, the temperature excursion was 8.5 (6-14) degrees Fahrenheit for a time frame of 18 minutes and 11.9 (6-14) degrees Fahrenheit fot 1 hour. There was no previous excursion.
10 days after immunization on 9/16/03, began with fevers and arthritis and diagnosed with systemic Juvenile Rheumatoid Arthritis. Kawasaki disease. Juevenile rheumatoid arthritis, systemic manifestation. Follow-up: Continues to have JRA but doing well on medications. Per annual follow up report still rash on stomach 12/4, M says he is occasionally stiff. Intercurrent infection with toxoplasmos is last spring has clouded the picture.
Pfizer-BioNTech COVID-19 Vaccine EUA - Lips tingled 2 minutes after injection, then moved to tongue.  Lips started to go numb along with tongue, face started to itch right after.  Within 30 minutes of injection, eyelids were swelling, face and chest redness, whole body itching.  Benadryl and Tylenol taken, symptoms were lessening within 1 hour of taking Benadryl.
I developed hives on my face.  Around 12:30 I noticed an itchy spot on  the right side of my chin.  It wasn't until my shower around 22:00 that the redness developed noticeably.  After exposure to the heat  hives popped up all over my face.  They don't visibly extend past the hairline or onto my neck  and aren't anywhere else on my body that I can see.  I took one generic Benadryl  at 7:00 the morning of the 6th but have not noticed any improvement (or worsening of my symptoms) I was examined by the Nurse Practitioner and MD at a clinic and they agreed to the diagnosis of hives and recommended switching to Zyertec.
Patient reports feeling "fine" after injections.  Around 11 AM she became dizzy and lightheaded while driving. She hit a light pole as a result of momentarily "blacking out" while driving.
Post vax, the pt experienced shooting pains in the neck and head, extreme pain in the feet.
No Adverse event occured. We realzed on 11/16/23 that we administered full vial instad of 0.25ml. Therefore, 0.5ml was given.
Inadvertently gave Meningococcal to soon. No S/S of any reaction.
The patient returned to the pharmacy today, 1/24, to pick up prescriptions for pain and adverse events stemming from receiving her second dose of SHINGRIX on Saturday, 1/19. The patient was seen by her doctor today and informed me that she has had severe arm pain, redness, swelling at the injection site as well as flu-like symptoms (she said all of the symptoms on her VIS at one point or other during the conversation.
Woke up on 1/22/21 with severe vertigo and dehydration that progressed throughout the day.  Took Benadryl around 12:00 PM, and slept throughout the day.  Woke up with still vertigo.  Went to sleep, woke up Saturday very, very light headed and again dehydrated.  That progressed throughout all of Saturday and Sunday.  Monday was a little bit better still a little lightheaded.  This morning woke up a little better but still light headedness.  No FU with doctor.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought any medical attention. This is one of several reports received from the same source. Additional information has been requested.
This 77-year-old female subject was enrolled in an open label study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) 50 ug on 6th June 2016. On 21st October 2016, 137 days after receiving Zoster VZV-gE-AS01B, the subject developed severe - grade 3 knee pain. Serious criteria included hospitalization. The outcome of knee pain was recovered/resolved on 21st October 2016. The investigator considered that there was a reasonable possibility that the knee pain may have been caused by Zoster VZV-gE-AS01B. Relevant Tests: unknown at this time - site to request medical records. Investigator text: unknown details at this time- site will request medical records for additional details. Additional details: Investigator has reported SAE as increase in right knee pain. "This case was deleted in database under the reason-created in error-NO SAE (planned surgery). Case was undeleted on 01Nov2017".
After getting shot. I sleep tight and I pained my left arm tomorrow  May 5, 2021 I began to have difficulty breathing . I took medicine Omeprazole dr 20 mg capsule . I still had difficulty breathing through May 15,  2021. Please check again about the last digit . Nurse : wrote lot number EW0172  or EW017Z. She wrote 2 or Z . It s not clear about that. I don?t know is number 2 or letter Z. Thank you
Associate immediately felt flushed; about 15 minutes later; associate felt numb feeling in her lips; cheeks; tongue - those sx subsided following administration of 25mg IM Benadryl.  Associate also developed red rash on her chest and bilateral arms.  Pt. reports was also feeling diaphoretic.  At this time, the pt. reports feeling warmth chest/neck area.  Pt. is speaking in complete sentences.  Pt. reports slight headache in back of her head.
Patient given injections eastern standard time 3:00pm 06-14-2005. Patient awoke at 10:00pm wheezing whole body jerking motions, twitching, temperature 101.5-102. On 06-15-2005 100 degree in am, no jerking. Appointment made-post immunization fever and upper respiratory infection given      continue TYLENOL/MOTRIN.  6-16-2005 mom notified office patient was jerking again after nap on 06-15 fever 101 degrees in night.  Appointment if not resolved today
extremly hot; extremely swollen; quarter sized blisters; covid arm; sweats; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm) and HYPERHIDROSIS (sweats) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-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 FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 2 dosage form. At the time of the report, FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Patient inadvertently received the adult dose of the Covid Pfizer mRNA vaccine. No immediate adverse reactions noted.
7 days, post vax, developed rash, redness on perimeters and raised with clear centers; some fluid filled in appearance which lasted 96 hours. 8 days, post vax, fever to 101F (ax), lasting approx. 72 hours. Treated symptoms with Tylenol and Motrin.
Initial unsolicited literature report received from a healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090260, 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. A female patient, whose medical history and concomitant medications were not reported, had received a dose of TDAP and a dose of HPV4 (batch number, route and site of administration were not reported for all vaccines) on unspecified date. On unspecified date after vaccinations, patient experienced chorioamnionitis and it was reported that patient was pregnant during vaccination. The last menstrual period and estimated date of delivery were not reported. Pregnancy exposure timing was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Two days after the 2nd dose of the vaccine I started breaking out in hives on my right arm.  Later that night it had spread to my right arm and parts of my legs. When I woke up Saturday it had spread further to  the front and back of my  thighs . By Saturday night both of my feet were swollen along with my hands. By Sunday morning it was all over my back my neck and face and my eyelids were swollen. It was then that I went to the ER at the Hospital. My vaccination was done in sporting event stadium.
After 4 hour post vaccination patient had extreme fatigue, went to sleep, woke up at 2 am with sore throat and said it was difficult to swallow because golf ball size feeling in throat. She said her voice was raspy and sore for 2 more days. Claims to be highly allergic to latex products. No latex or natural rubber in the prefilled syringe product.
Large red, feverish circle appeared around injection sight producing excessive itching, redness and raised inflammation.
pt devel erythema (8.5 x 5cm), edema, & tenderness @ the inject site p/receiving Td;
SKIN REACTION, ERYTHEMA 8CM X 7 1/2CM, NO SIGN INDURATION, NOT PAINFUL, NOT ITCHING
Smallpox vaccine was given at approx. 8:15 p.m. I was giving site care instructions and noticed she was scratching herself all over her body. She stated it was like when she had penicillin. No rash was noted and she did not have any respiratory distress. She cont. to itch this a.m. Treated with Zyrtec.
minor rash on upper chest 2 days post Zostavax, nonvesicular itchy mild lower eyelid swelling
Left arm was extremely sore with limited motion.  Most of entire left arm was inflamed and red in color.  Experienced overall body muscle and aches as well as a headache.
Loss of eye contact, loss of developed language, loss of social skills gained, diagnosed with Aspergers at age 4. Yearly titer test high for MMR. Currently experiencing neurological deterioration (tremors, increased aggression, balance problems, cognitive changes.  No history of childhood disease.
Confusion, Myalgia, Fever, unable to sleep; temperature up to 100.2F; fatigue Narrative:  OTC Tylenol and Motrin
inc in temp & swelling w/erythrocynosis; treated w/ice to area & apap; cont for 1wk;
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211209775, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210197, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082, 20211212088, 20211209782, 20211209740, 20211209706 and 20211209679.
10-11 days after shot, I developed dramatic itching and hives and dermatographia. I received Depo-Medrol and medication regiment that helped temporarily. It returned once I stopped the medication. The itching has not gone away and is impacting my whole body. It tends to change location, thighs, back and arms.
Involuntary error, vial Pfizer Biotech pediatric vaccine was diluted with 0.3ml of 0.9% sodium Chloride instead of diluting with 1.3m. Dose was administered to patient with 0.2ml after dilution.