chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection was more painful than typical for influenza. After three day, should pain became worse. After a week, range of motion started to deteriorate and sharp pain became worse. By three weeks, could not move my should without stabbing pain, could not lift a coffee cup, pain radiated to scapula, neck, side of shoulder. Felt like rotator cuff tear. Impaired sleep, almost complete loss of range of motion. Started researching if a vaccination could cause tendonitis or shoulder injury and learned bout SIRVA. Started taking large doses of Tylenol and symptoms started to remit over the next week. Have regained range of motion and most of my strength back. Still have pain when sleeping and lifting arm above head.
chills; fever; pain in the right arm; first dose of Shingrix vaccine in December 2019 and has not received the second dose yet; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression and rheumatoid arthritis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, fever, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the chills, fever and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In December 2019, the patient received the 1st dose and still not received the second dose, which led to Incomplete course of vaccination. The patient reported the day after receiving the vaccine she had fever, chills, and pain in the right arm and these effects lasted 2 to 3 days and then resolved.  The reporter did not consent to follow up.
Notes: Pt was instructed by MA to stay sitting for 10 minutes administration of HPV vaccine. HPV and flu vaccine given, approx 1 minute after HPV vaccine, pt stated to mom she didn't feel well, was sitting and then fell back onto table and started making jerking movements, eyes rolled back- BP was 118/68, pulse ox ws 98, Pulse was 72, pt came to in approx 1 minute, aware of person place and time, stayed laying for 2 minutes then sitting for 5 minutes and returned to normal. Mother and pts younger brother in room during entire incident, MA was called in when pt fell on table, I was called in by MA and was in room until pt stablilized. I discussed in detail that pt fainting and having jerking movement is a known side effect of HPV vaccine. Pt did not have seizure activity (no hx of seizures as well). Mother to make known to other providers pts vaccine reaction this time and be cautious with subsequent flu vaccines as well (likely HPV vaccine reaction but pt did recieve Flu vaccine at same time so needs to be aware). This is pts 3rd HPV vaccine and she has completed the series- had never had reaction to HPV before. Mother reassured that this is a known HPV side effect- cdc information printed and given to her for more information. No injuries sustained during this incident.
FELT TIRED FOR 24 HOURS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18G5031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced felt tired for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired for 24 hours on 18-MAR-2021. This report was non-serious.
redness; swelling; Pain in left armpit; tenderness in left armpit; swelling of the lymph nodes in the left armpit; Fatigue; headache; muscle pain; joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit) and LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Migraine and Asthma (on asthma inhaler - not used in over a year). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, RIZATRIPTAN for Migraine.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), AXILLARY PAIN (Pain in left armpit), LYMPH NODE PAIN (tenderness in left armpit), LYMPHADENOPATHY (swelling of the lymph nodes in the left armpit), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient takes migraine medication more often than inhaler due to using the computer for work.  Patient reported that the second dose was the worst.   This case was linked to MOD-2021-405038, MOD-2021-405022 (Patient Link).
Pt developed urticarial rash on eye, neck and trunk with itching lasting for 2-3 hours. Treated with Zyrtec.
Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: Nurse reported that a patient received an expired dose of Havrix The reported consented to follow up. Additional Supportive Information: The patient received havrix which was already expired, which led to expired vaccine used.
Developed acute varicella on 3/28/07 8 days after receiving Varivax.
Large, circular swollen area on thigh where administered, tight, red, itchy not painful... was given Augmentin and told it was Cellulitis and that if it did not clear up in next day or so that we would be admitted to hosp. for intravenous antibiotics.
vertigo/dizziness; vertigo/dizziness; Chills; body aches; extreme tiredness; bilateral ear pain; nausea; No appetite; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at let arm on 19Jan2021 17:00 at single dose for covid-19 immunization. The patient was not pregnant. The COVID-19 vaccine was administered at Hospital. The patient medical history reported as none. Concomitant medication included cimicifuga racemosa (BLACK COHOSH), curcuma longa (TURMERIC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on 29Dec2020 07:00 at left arm for covid-19 immunization. The patient experienced Chills, body aches, extreme tiredness (slept for 30+ hours), bilateral ear pain, nausea - this all started 15 hours after 2nd dose on 20Jan2021 08:00, and then vertigo/dizziness started 4 days after 2nd dose on 23Jan2021, and also experienced no appetite from an unknown date in Jan2021. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
fatigue; slight body aches; This is a spontaneous report from a contactable nurse (the patient) via Pfizer sales representative. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue and slight body aches on an unspecified date. The clinical outcome of the events fatigue and slight body aches was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
An eight year old male developed chickenpox that consisted of 40 lesions on 2/8/99, after being exposed to his 4 year old sister who was vaccinated with first dose of varicella virus vaccine live on 01/06/99. The pt was not immunized against varicella. The vaccinee experienced chickenpox 9 days post vax. It was reported that the pts younger brother, who was not immunized against varicella experienced a similar episode.
Pt received oral Tylenol 09/09/2005. 1st dose taken approx 4pm. Pt had slight fever and flu like symptoms. Next dose was 09/11/2005 pt had fever 102.5. Fever remained elevated on and off next day also. chills and flu like symptoms. also abdominal pain which was severe at times.
Chills, 103.2 fever, and fatigue. at 06:00 pm Took Tylenol and Aleve at about 8:00 pm. Woke up at 3:00 am with no more fever and 50% better with bed sheets soaking wet. Went back to bed. Woke up at 9:00 am  on 02/20/2021 and was 90% better.  On 02/21/2021 09:00 am 100% better.
pt recvd vax 25OCT95 & reddened area appear next day around site of inj;travelled around side of arm;many red streaks & one large red area on ? deltoid toward arm pit;blood poison; sore
fever; chills; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization (at the age of 16-year-old). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient health details was unaware. The patient experienced fever, chills, headache and nausea on an unspecified date. Event took place after use of product. Side effects lasted about half a day. Outcome of the events was recovered on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
redness she had in her arm; soreness she had in her arm; swelling and soreness she had in her arm; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season and PNEUMOCOCCAL VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cellulitis (serious criteria GSK medically significant), allergic reaction, swelling arm, pain in arm and erythema of extremities. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, allergic reaction, swelling arm, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the cellulitis, allergic reaction, swelling arm, pain in arm and erythema of extremities to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received flu vaccine and pneumococcal vaccine at the same time in same arm and experienced redness, swelling and soreness in arm and was prescribed antibiotics for cellulits. The patient went to urgent care for redness, swelling and soreness in arm. The primary care physician did not think it was cellulitis but just an allergic reaction. The reporter was not sure exactly which vaccine caused the issue. The patient was seeking to get another flu vaccine, but was taking zejula and wanted to know if  She can get the flu vaccine.
covid like symptoms; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (covid like symptoms) and HYPERHIDROSIS (Sweating) 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SUSPECTED COVID-19 (covid like symptoms) and HYPERHIDROSIS (Sweating). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (covid like symptoms) and HYPERHIDROSIS (Sweating) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
Initial unsolicited report received from a pharmacist on 27-Sep-2018. This case involves a 44-year old female patient who was vaccinated with a dose of 0.5 ml FLUZONE HIGH DOSE on (Batch number: 250785, exp: 30-Apr-2019) via unknown route in the left deltoid) on 25-Sep-2018. The patient's medical history and concomitant medications were not reported. No concomitant vaccines given. It was an actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse event occurred. 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. List of documents held by sender: none.
NO ADVERSE REACTIONS OCCURRED. DOSE WAS DRAWN BUT A VIAL THAT WAS PUNCTURED > 12 HOURS AGO (11/18/22 106 PM) AND ADMINISTERED 11/19/22.
Sever epigastric pain waking me up at 3:00am 14hrs after vaccination, nausea, flushing.  Pain lasted throughout the morning, waxing and waning.  By 4pm symptoms are mostly resolved.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter states that he thinks the patient got full dose instead of a booster dose and the administrating pharmacist states she got a booster dose. This case was linked to MOD-2021-422964 (Patient Link).
6/5/15 lump at (L) deltoid site, 6/7/15 larger lump, 6/8/15 redness from site to elbow, itching, tiny bump to elbow, hard area around (L) arm at level of injection site. Entire (L) upper arm at affected, worse on outside of arm. Pt applied calamine 6/9/15 until resolved. Zyrtec 6/9/15 to 6/16/15. Sx resolved 6/23/15. Pt reported reaction on 6/15/15 when she was improving.
pt c/o SOB, high blood pressure, dizziness & ha/; EMS started IV ;
'You were evaluated for your rash and discomfort after having the influenza vaccine. Your exam was otherwise reassuring and you were given medication to help your symptoms, Patient status post receiving a flu shot approximately one hour  prior to arrival in having nausea and lightheadedness. We'll give the patient IV fluids as well as Benadryl.' FINAL ED DIAGNOSIS: Med Reaction  PRESCRIPTIONS:  BENADRYL 25MG PO Q6H FOR 2 DAYS.
bleeding vaginally  four days after receiving her first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable Nurse. This contactable Nurse reported for a 19-year-old female patient that:   A 19-year-old female  patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), dose 1 intramuscular, administered in Arm Right on 22Jan2021 13:30 (Batch/Lot Number: EL9262) as dose 1, single for covid-19 immunization. Medical history included Drug hypersensitivity from an unknown date and unknown if ongoing penicillin allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced bleeding vaginally four days after receiving her first dose of the Pfizer Covid 19 vaccine on 26Jan2021. Nexplanon removal & IUD insertion treatment was received for event bleeding vaginally four days after receiving her first dose of the Pfizer COVID 19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and also since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "Vaginal haemorrhage" and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.
1. This was a medication error. 2 Year old scheduled for the Moderna Vaccine received Pfizer Pediatric 5-11 dosage of 10 mcg. This was reported to our Peds ID MD Dr. who stated that the potential for harm is low and recommendation was for the child to return for dose 2  of Pfizer 6mo -4 year in 21 days. Parent was also informed of error and recommendations.  2. On 7.29.2022 Nursing Supervisor placed a follow up call to parent to check on the child. Mom stated they were in Urgent Care due to a rash that had developed to bilateral arms and patches of a rash noted to arms and legs. Parent reports rash was non itchy. Parent reported no respiratory difficulty. Parent reported child slept well and was eating, drinking and acting like a normal toddler.
Fatigue, restless sleep, and tingling of the legs. No medications taken. Side effects have resolved.
No adverse event - Patient inadvertently received LAIV during pregnancy on 15 Dec 2015. 34 y/o female. G3 P2. LMP - 15 Aug 2015. Follow up at OB and GYN Clinic. Final EDC - 21 May 2016. Pregnancy outcome: healthy baby boy delivered by C-section. Birth weight: 3675 grams. Apgars: 9/9.
At 12-36 hours decreased responsiveness. Not irritable but would just sit in front seat and act as if dazed. In crib reportedly just laid with little minor movements. Not interested in anything. At 48 hours acted normal.
HD Flu vaccine given on 10/7 and 48 hours after (10/9) flu vaccine was given patient began having redness and swelling to entire left upper arm. Skin is warm to the touch. No issue with ROM of the shoulder or pain at the joint. Patient was treated with Keflex 500mg capsule QID x 10 days. Patient was scheduled for a follow up call tomorrow 10/10 to see if symptoms are improving. History: Patient did receive the HD Flu vaccine last year with no issues.
pt recv vax 27JAN98 & awoke w/fever, vomiting x1, lethargic, & c/o tiredness;c/o being tired since 8FEB98;11FEB98 awoke w/one red spot on rt side of face; has 4-6 spots as of 13FEB98;MD stated it was probably a rxn;
Covid vaccine, unknown manufacturer. Right shoulder pain, decreased range of motion starting 1 hour after injection. Injection site appeared high on the medial deltoid upon exam 2 days after injection.
(L) anterior thigh 13 x 11 erythema and swelling. (R) lateral thigh 5 x 5 firm erythematous plaque. BENADRYL and ice f/u as needed.
Patient felt dizziness once standing up to leave after waiting 10 min post vaccine. This resolved after lying on the ground and elevating his feet.  He also experienced some sweating during the dizzy spell. After about 40 minutes, all his symptoms resolved.