chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper back and neck pain; upper back and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 13Dec2021, outcome "unknown" and all described as "upper back and neck pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, back pain.  Additional information: The adverse events were treated with Ibuprofen 400mg, 1 every 4 to 6 hours, maybe twice a day. The patient underwent the following laboratory tests and procedures: x-ray: (21Dec2021) negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches, nausea, chills,  Took ibuprofen and Tylenol, drank lots of liquids, rested in bed all day. Symptoms only lasted 24 hours. Felt fine next day. Arm still a little sore.
Developed herpes zoster within 5 days of 1st Covid vaccine injection and developed herpes zoster within 24 hours after 2nd injection. The 1st infection had completely cleared before the 2nd infection; 2nd infection is much more painful; blisters/patches are larger; This is a spontaneous report from a contactable Nurse. This 52-year-old female Nurse (patient) reported for herself that:  A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 23Apr2021 12:15 as DOSE 1, SINGLE, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Apr2021 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hashimoto's thyroiditis, latex. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 24Apr2021 12:00, the patient experienced developed herpes zoster within 5 days of 1st covid vaccine injection and developed herpes zoster within 24 hours after 2nd injection. the 1st infection had completely cleared before the 2nd infection, 2nd infection is much more painful, blisters/patches are larger. Therapeutic measures were taken as a result of developed herpes zoster within 5 days of 1st covid vaccine injection and developed herpes zoster within 24 hours after 2nd injection. the 1st infection had completely cleared before the 2nd infection, 2nd infection is much more painful, blisters/patches are larger. Events resulted in doctor or other healthcare professional office/clinic visit/physician office visit. The clinical outcome of events were not recovered.    No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pediatric patient given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 3 months old male patient who given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation.  On 23-Dec-2021, the patient received dose: 2, 0.5ml total, dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ577AAA exp: date: 10-Sep-2022 via intramuscular route in the left vastus lateralis for immunization.  On 23-DEC-2021 the patient given first dose of pentacel at the hospital at 2 months of age and given the 2nd dose at 3 months of age as mother did not disclose that first dose given at 2 months of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event.     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 the 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.
Pt recvd vax on 3SEP91 & grandparent was hospitalized 23SEP91-11OCT91 w/progressive motor paralysis (no sensory loss) in lower body; dx anterior horn cell dysfunction, secondary to polio vax or other picorna viruses;
On the first day all symptoms were light, pain in tailbone, joints (mainly knees), right hip, entire back, slight chills. When I woke up on day 2 all the afore mentioned were intense and I could not sit or stand without pain, so I had to lie in bed. Day 3 ditto day 2 then by the evening the chills went away, and pain had less intense, but I still only could lie in bed.   Day4, 1: 00 am I woke up with the bad chills.  The rest of the day I also just laid in bed.  Finally on day 5 the pain is gone but I still have the feeling like I'm about to have the chills, my hands and feet are ice cold, but I don't need to stay in bed. Today is day 5 so I am not sure what the future days will be
3 hours after injection extreme fatigue. 15 hours after injection I was awaken by extreme pain in my left armpit (same arm as injection sight), injection sight severe pain, and severe flu like symptoms, chills, aches, headache, stiffness, muscle aches, out of it, could not think straight or process simple things and I probably should not have driven...these symptoms were so severe I had to get Ibuprofen ingested and lay back down before I could even get out of bed to cancel a plane ticket by phone. I could not even think or walk. I felt my left armpit and it was extremely painful and swollen (I have pictures) 4 hours after taking the Ibu and going back to bed I awoke and had same symptoms for the next 3 days but also nausea. Went to urgent care clinic 24 hours after injection and was negative on flu test. Went to my GP on Monday 72 post injection and he ordered an ultrasound of my armpit. Benign reactive lymph nodes. This took almost 3 weeks to resolve. In the days that followed I had tingling, numb feet, the ear ringing (still), and am wiped out by 6 pm almost daily. I am a high energy person in excellent health so this is disturbing issue. From onset to present is a high pitched, tin like ringing in my ears constantly.
Slight allergic reaction; Tongue tingled; Pulse went up to 118 within seconds; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision). On 13-Mar-2021, PARAESTHESIA ORAL (Tongue tingled) had resolved. At the time of the report, HYPERSENSITIVITY (Slight allergic reaction), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 118 (High) pulse went up to 118 within seconds.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.
RINGING IN THE EARS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 01-OCT-2021) dose was not reported, 1 total, administered on 07-AUG-2021 at left deltoid for prophylactic vaccination. It was reported that patient was fine following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 08-NOV-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in DEC-2021, (a little bit after thanksgiving) she began to experience ringing in both ears, but left one was louder. She stated that the ringing was all the time, the ringing did not sound like a bell but more like crickets or peepers. She stated that the symptom was not going away or subsiding. She noticed the ringing at night first when it was quiet, and since then it had progressed and she was experiencing at the time of reporting while she was on the call. She also mentioned that she had not brought that issue up with her physician yet, but planned to bring that up in the future if she still had it in 6 months (event with dose number series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ears. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated; manufacturer unspecified given on 9 December 2007. On 09 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
Patient developed severe diarrhea and had blood in her stool following rotateq vaccination. No constipation, no rashes, no diaper rash or open wounds around diaper area. Did have mucous in stool with streaks of frank red blood. Did not give rotateq at 4 month visit and did not have these symptoms again with pentacel and prevnar. First blood 6 days after rotateq vaccine and diarrhea x 2 days following vaccine.
Headache & NauseaVomiting Narrative:  day 1-3- sore arm, ha/nausea; day 3-4- n/v; day 5- nausea
p/vax pt c/o pain & aching in jaws, ankles & back of neck;also c/o deep muscle pain;pain  inc when extends & rotates arm;large tender, swelling @ the inj site rt shoulder;
This case was reported by a healthcare professional and described the occurrence of elevated liver enzymes in a 10-year-old female subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline).  Concurrent vaccinations given on 29 July 2008 included the 3rd dose of VARIVAX; Merck; unknown.  On 29 July 2008, the subject received the 1st dose of HAVRIX pediatric (unknown, left arm).  During the same office visit, on 29 July 2008, blood work was taken by the physician.  On 07 August 2008, results of the blood work showed that the subject had elevated alanine aminotransferase (ALT) of 308 (units unspecified, laboratory normal range reported to be between 2 and 40); and elevated aspartate aminotransferase (AST) of 175 (units unspecified, laboratory normal range reported to be between 4 and 35).  Due to the elevated liver enzymes, a hepatic panel was taken on an unspecified date for further evaluation.  On 26 August 2008, the results of the hepatic panel showed that the ALT level of 29 (units unspecified) and AST level of 27 (units unspecified) had returned to normal.  The hepatic panel also showed immunoglobulin M reactivity.  Per the reporting nurse, the mother of the subject stated that the child did not feel well and had been vomiting in mid August (date unspecified).  No treatment has been required for any of these events at the time of reporting.  The subject's mother also provided information that the child had possibly been exposed to the hepatitis a virus via commercial contact at a restaurant, either a couple of days before or after the vaccination with HAVRIX.  Thus, the causality for HAVRIX is not known at the time of this report due to the confounding factor of the possible hepatitis A exposure.  This case was assessed as medically serious by GSK.  At the time of reporting, the outcome of the elevated liver enzymes (ALT and AST) were resolved; the outcome of the vomiting and not feeling well was unknown; and the abnormal blood immunoglobulin M was unresolved.
anaphylatic reaction; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01May2021 (Batch/Lot number ER8735) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included connective tissue disorder from an unknown date and unknown if ongoing .she has a lot of history with allergies to drugs. In 2009, for the H1N1 pandemic, she got the vaccine and then she had Bells Palsy. After that, she got an autoimmune disease which may or may not have been due to the vaccine. she got the Varicella vaccine and she got a racing heart and could not breathe and she had to sit in the emergency room. A year ago, she got the tetanus vaccine and had no reaction. She takes antihistamines to that. She states she and her sister have Ehlers Danlos, which is a connective tissue disorder.she did not visit an emergency rom of physician's office. The patient's concomitant medications were not reported. The patient experienced anaphylatic reaction on an unspecified date with outcome of unknown.    Follow-up (18Aug2021): Follow-up attempts completed. No further information expected.  Follow-up(27Aug2021): This is a follow-up spontaneous report received by a contactable consumer. This female consumer(patient) reported in response to Non-HCP letter which includes that: The first dose was taken on 01May20212021 at 03:30 PM The Site and Route of injection is Right Deltoid and Route of administration is Intramuscular. The concomitant medications included, Levothyroxine 100 mcg since 2009, Modafinil 50, Vitamin D3 2000IU/day for thyroid since 2009, Famotidine for GERD. Patients medical history included Ehlers Danlos, Multiple Sclerosis and Low thyroid since 2009.Family medical history relevant to AE(s), Her sister had facial swelling after dose 2, Bronchospasm or chest tightness on 05Jan2021.Treatment taken with Benadryl 50mg 1 time.Also have a different indication of rash that wont go away. Started 5-5 Looks like eczema but doesn't respond to cream. Gets worse in sun.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer. A 21-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 21, via an unspecified route of administration, left arm, on Feb 28, 2021, single dose, for COVID-19 immunization, at a school. The patient's medical history included asthma. Allergies included acetaminophen, ibuprofen, cephalosporins, monk fruit and spinach. No other vaccine administered in four weeks. No COVID-19 prior vaccination and no COVID-19 tested post vaccination. 24 hours after vaccine, on Mar 1, 2021, at 10:30 am, patient  developed a low-grade fever (99.8ºF), muscle aches and weakness; with outcome of not recovered. No treatment received for the adverse events. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Pt presented with < 102 deg Fever, convulsions and apnea. Pt's heart and breathing stopped, CPR was done, pt responded quickly, four rounds of CPR done, estimated seizure time of 4 mins total. Pt transported to ER per ambulance at that time. The discharge summary received on 3/23/04 states febrile seizure and RSV (+).
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA006787: US-009507513-1805USA009899: US-009507513-1805USA009900: US-009507513-1805USA009901: US-009507513-1805USA009902: US-009507513-1805USA009903: US-009507513-1805USA009904: US-009507513-1805USA009905: US-009507513-1805USA009906: US-009507513-1805USA009907: US-009507513-1805USA009908: US-009507513-1805USA009909: US-009507513-1805USA009910: US-009507513-1805USA009911: US-009507513-1805USA009912: US-009507513-1805USA009913: US-009507513-1805USA009914: US-009507513-1805USA009915: US-009507513-1805USA009916: US-009507513-1805USA009917: US-009507513-1805USA009918: US-009507513-1805USA009919: US-009507513-1805USA009920: US-009507513-1805USA009921: US-009507513-1805USA009922: US-009507513-1805USA009923: US-009507513-1805USA009924: US-009507513-1805USA009925: US-009507513-1805USA009926: US-009507513-1805USA009927: US-009507513-1805USA009927: US-009507513-1805USA009927: US-009507513-1805USA009930: US-009507513-1805USA009931: US-009507513-1805USA009932: US-009507513-1805USA009933: US-009507513-1805USA009934: US-009507513-1805USA009935.
Within 2 weeks post vax, the patient became very ill. The patient started to show signs of Lymes disease. The patient developed aches and pains, a loss of energy and flu-like symptoms were quite severe.
excursion max: 11.6 C for one hour; excursion max: 11.6 C for one hour; This is a spontaneous report received from a contactable nurse. A pediatric patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date as single dose for immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that, seeks stability; excursion max: 11.6 C (degree Celsius) for one hour, non single excursion. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268716 same reporter/drug/event, different patient.
A report was received from a health care professional on 12/11/03 concerning a female vaccinee of unknown age who experienced swelling, redness and warmth on the arm and shoulder on the same day or the day after receiving Fluvirin on 12/5/03. On 12/5 or 12/6/03 the vaccinee complained of local reactions with swelling, redness, and warmth on the arm and shoulder. The symptoms had resolved on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Update 3/9/04: Follow up information received from a health care professional indicated that at the time of the event the vaccinee was 64 years of age. On 12/5/03 the patient also developed a rash without erythema approximately the size of a silver dollar. The rash resolved on an unspecified date. The reporter has clarified the causality assessment of the swelling and rash to Fluvirin as probable. No follow up pending, all information received.
pt came to pharmacy wanting a covid shot with online form already filled out.  RN on duty took in form, gave vaccine. No ill effects, just that pt was not 18
My arm was so sore on the left side that I could barely move it. I had a fever which got worse over time (up to 101 by 2:30 am last night). Also, chills, aching, and a slight headache. I finally ended up taking Advil for the fever sometime around 2:45 am which brought the fever down. When I got out of bed this morning (about 8:30 am) the fever had resolved and the left arm movement was noticeably improved.
Patient developed acute mental status change, gait instability, confusion, and seizure like activity several hours after vaccine administration.  Presented to the ER the following day for evaluation and was found to have acute CVA with embolic phenomenon confirmed on MRI, radiologist felt possible demyelination
Veteran received vaccine, sat in waiting area for 15  minutes. left with wife and then returned about 15 min later. Veteran reported "hives" on his face. Small fine red bumps observed on both cheeks, neck and anterior and posterior trunk. Veteran denied shortness of breath, itching, swelling of tongue and lips. No angioedema observed. Veteran given 50mg PO Benadryl and observed for additional 15 minutes. Veteran escorted to his car, wife present and waiting. Provided information on contacting 911 for any breathing issues/difficulty.
pt exposed to a child who was vaccinated w/ varivax;pt devel chicken pox;child who recv vax did not devel any sx of chicken pox;