chrisvoncsefalvay/vaers-outcomes huggingface dataset:
haven't got her second shot; elevated blood pressure; body has been cold ever since she took vaccine; loss of appetite; slept all week; sore arm; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (haven't got her second shot), BLOOD PRESSURE INCREASED (elevated blood pressure), FEELING COLD (body has been cold ever since she took vaccine), DECREASED APPETITE (loss of appetite) and SOMNOLENCE (slept all week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), FEELING COLD (body has been cold ever since she took vaccine), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept all week), MYALGIA (sore arm), NAUSEA (Nausea) and VOMITING (vomiting). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (haven't got her second shot). On 25-Mar-2021, SOMNOLENCE (slept all week) outcome was unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (haven't got her second shot), BLOOD PRESSURE INCREASED (elevated blood pressure), FEELING COLD (body has been cold ever since she took vaccine), DECREASED APPETITE (loss of appetite), MYALGIA (sore arm), NAUSEA (Nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient has not got second shot. Soon after the first shot had Nausea, loss of appetite, vomiting, slept all week, body had been cold ever since took vaccine, sore arm, and elevated blood pressure. Concomitant medication and treatment medications details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-138802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138802:
Patient had stated to technician that he was very afraid of needles and extremely nervous and that he thought there was a possibility he would pass out based on his previous experiences. Patient was ok after vaccination for about 15 second, then got very dizzy and light headed. He leaned over on the table and remained there for several minutes. I had a wheelchair brought over for him to sit in once he was confident in getting up. He felt more secure in the wheelchair than in the waiting chairs because those have no arms. He stayed in front of the pharmacy for about 30 mins while he recovered. He eventually felt good and wanted to stand and move around on his own. He decided to make a few laps around the store to be 100% sure that he was good before leaving. He assured me several times that he was feeling better.
Information has been received from a female consumer who on 18NOV2010 received a dose of PNEUMOVAX 23 (dose unknown) (lot#667912/0933Z). On 19NOV2010 the patient experienced an "acute allergic reaction" after receiving the vaccine. The outcome was unknown. Additional information has been requested.
Body aches pains extreme nausea and chills 8-12 hours took some Aleve
Diffuse hives lasting approximately 15 hours  on face, neck, torso, bilateral arms, back of both knees and bilateral axilla.  Patient had other typical post vaccine symptoms of headache, dizziness, nausea and joint pain.
About 5 hours after the administration of the Pfizer vaccine I started to experience a mild headache. About 9pm I started getting body aches, fever, chills, joint pain, fatigue, weakness, and nausea,.  The back of my neck and back hurt the worst. I also experienced leg pain and my feet hurt pretty bad. I could not move without hurting.  The fever lasted all night off and on. The next day the fever continued but it was low grade. The body/muscle aches continued but not as bad as the day before. The fatigue was worse during the second day.  On the 3rd day after the vaccine I felt almost normal.
bilateral elbow pain; intermittent anesthesia; paresthesia left hand; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 12Apr2021 (at the age of 48 years old) as dose 2, single for COVID-19 immunisation. Medical history included mild intermittent asthma and COVID-19. The patient's concomitant medications were not reported. The patient previously took cephalexin and experienced an allergy. Historical vaccine included bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 (at the age of 48 years old), via unspecified route of administration, administered in the left arm, as dose 1, single for COVID-19 Immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in 2021, it was reported that the patient experienced bilateral elbow pain lasting 3 months after second dose associated with intermittent anesthesia/paresthesia left hand. The patient received NSAIDs as the treatment for the events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Information has been received from a healthcare professional concerning a pt who was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). Subsequently, the pt experienced cellulitis at the injection site that extended all the way down the arm. The pt was seen in the physician's office for examination and treated with antibiotics. It was noted that the pt was afebrile. Another pt (WAES 00061885) had a similar experience. Additional information has been requested.
Information has been received from a registered nurse concerning a 28 year old female patient with asthma, allergies an allergies to penicillin, CECLOR, and CIPRO who was vaccinated on an unspecified date with the first and second doses of GARDASIL. Concomitant therapy included BACTRIM, Albuterol , and allergy immunotherapy and allergy medication. The patient was given GARDASIL in the gluteal area for both doses. The patient developed pain at injection site after receiving each dose and pain had not resolved. The patient also experienced fever and malaise fro several days after both doses. Malaise and fever had resolved.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius) for 16 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. is 11 year old female scheduled by mother for first Pfizer vaccine. Pt. received vaccine and it was discovered at checkout that pt. birthday was entered incorrectly to make the patient appear 12 years old at time of vaccination. On discovery, site supervisor was contacted and discussed the occurrence with the patient's mother. The patient's mother reports lying about the child's age in order to have her receive the vaccination. I obtained consent to report the occurrence via VAERS and I also educated the child's mother about the potential for side effects and that this is an off-label use of the vaccine. Mother verbalizes understanding of this.
Following the shot, I had the normal general aches and malaise for a few days,  I am a classical harpsichord player so have always had acute hearing.  About a week after the shot, the Tinnitus began and reached a level that is about the same as a person speaking with a soft voice in a living room setting (i.e. I  must now ask a person to speak up).  The effect on music is significant and has impacted my ability to play the harpsichord as well as enjoy listening to others.
RASH ON CHEEKS, NEAR MOUTH, NECK AND UPPER CHEST. DEFINED BORDERS. NOT RAISED, NO SWELLING, NO ITCHINESS, NO AIRWAY COMPROMISE. LUNGS CLEAR. Sp02=100% PROGRESSED OVER 10 MINUTES. REFUSED TREATMENT AND TRANSPORT. PERSONAL VEHICLE TO OBTAIN OTC ANTIHISTAMINE WITH FAMILY
fever of 105 began w/in 8hrs of vax w/MMR & tetramune (lasted <24hrs)
Palpations, cough, body aches, chest tightness, SOB, Headache, Fever,
abscess at injection site.  Improved with anti-inflammatory medication and oral antibiotics (doxycycline 100mg BID)
Information has been received from a physician via medical records concerning an 18 day old female with clicking hip, and a history of breast lump, band neutrophil count increased, jaundice, and group B betahaemolytic streptococcal positive (all reported in WAES 0806USA02242) who on 27-JAN-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 26-FEB-2009 the patient was vaccinated IM with a third dose of pediatric RECOMBIVAX HB (manufacturer unknown). The patient's sister was diagnosed with diabetes at age 4.  On 09-FEB-2009, the patient was seen by the physician for 2 week hearth care. It was reported that the baby stopped breast feeding "last night". She was fussy with breast milk. She had no major spitting up. Physical examination showed no abnormality. The doctor stated that she might use hydrocortisone cream 1% to face twice a day for 5 days. The patient was to be followed up in 2 weeks. On 25-FEB-2009, the baby was taken for an office visit by her parents. The parents had concerns about rash on her face behind ears and spreading to scalp which lasted 2 weeks. Physical examination showed acne in face, neck and scalp. The patient was diagnosed with acne. The doctor suggested to keep face clean with soap and water. On 26-FEB-2009, the baby presented to the office for 1 month well baby visit. Physical examination revealed pustules in scalp, Lactose intolerance was diagnosed during the visit. On 04-MAR-2009, the mother called to report that the child had chronic constipation. She had been using infant fleets enema. A nurse advised to stop and use karos syrup, 1-2 tsp in bottle once to twice a day. ON 24-MAR-2009, the patient was taken to the office by her parents for well baby visit. The parents had questions regarding formula. The patient was still very gassy, constipation. She used Miralax every two days. The parents wanted to start rice cereal at night. Physical examination showed no abnormailty. During this visit, the patient was vaccinated with a dose of PENTACEL, ROTATEQ oral, PREVENAR IM. The baby would be followed up in 2 months if age 4 months for well baby check. The patient experienced upper respiratory infection (WAES #0908USA00001) after being vaccinated with ROTATEQ. This is one of several reports concerning the same patient. Additional information is not expected.
Temp 103 24 hours after vaccine. (4 other kids same lot DTaP with elevated temp).
"COVID arm", big red bump at injection site, itchy and extremely sore. After redness  and swelling resolved, now (2 weeks later)  a shadow like mark remains where the bump was
Got GBS from this vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Got GBS from this vaccine) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-APR-2023 This case was reported by a patient via interactive digital media The reporter reported that he/she  got(Guillain Barre syndrome) GBS from this vaccine and shingles would had been much easier.
8 hives on scalp; 6 hives on neck; 5 hives on right arm; 1 hive on left arm; 1 hive on left ankle; 21 hives total-popped out on April 18, 19, 20, 21, 22. No temperature; Doctor prescribed Zyrtec
patient received an expired dose of PENTACEL/no AE; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Regulatory Authority (Reference number- 00694634).  This case involves a 2-month-old male patient who was vaccinated with an expired dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 20-Jul-2021, the patient received a 0.5mL of first dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number : UJ323ABA and expiry date : 13-Jun-2021) via an intramuscular route in the right thigh administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  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 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.
a red circle where I got the vaccine, it is still a firm nodule, itches lightly and is slightly warm (although I may just have warm skin in this office).
Information has been received from a physician concerning a 15 or 16 years old female patient who was vaccinated with the second dose of GARDASIL 0.5ml IM (therapy date, site unknown. Subsequently after the second dose, "In July or August, 2008", the patient experienced anaphylactic reaction. "Her throat started closing and she couldn't breathe." The patient was given BENADRYL and steroids (unspecified). The patient recovered that day. The doctor did not say if there was an AE with the first injection. Because of these events, the patient will not be completing the series. Upon internal review, the throat tightness and dyspnea were considered to be other important medical events. Additional information has been requested.
Headaches; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 for COVID-19 immunisation. The patient experienced headaches in 2021. It reported the patient still have headaches at the time of report. The outcome of the event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHEH2014US005880 is an initial spontaneous report from a nurse received on 24 Mar 2014. This report refers to a 40-year-old female patient. Her medical history and concomitant medications were not reported. She was mistakenly administered 0.1 cc of FLUVIRIN (batch number: 1309601) intradermally when TB test was intended on 24 Mar 2014. On an unknown date after vaccination she experienced red mark at the site. Seriousness, outcome of the event were not reported.
Sore arm from shoulder to bicep same day. Soreness still present 4 weeks later? still present. Cold symptoms  next day lasting about 3-4 days. Extreme fatigue starting that evening and still present. Leg pain about 12 days following vaccine? still present. Massive DVT groin to ankle diagnosed in hospital 18 days after vaccine? still present.
Systemic: Fainting / Unresponsive-Mild, Systemic: had slight panic attack-Mild, Systemic: Flushed / Sweating-Mild
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5ml SD-PFS LLok wTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day), INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) and HEADACHE (Immediately after received the vaccine had a headache) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day), INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) and HEADACHE (Immediately after received the vaccine had a headache). At the time of the report, MALAISE (feeling lousy), ILLNESS (been in bed for 5 weeks since received flu shot and Moderna Covid-19 vaccine on the same day) and HEADACHE (Immediately after received the vaccine had a headache) outcome was unknown and INFLUENZA (flu immediately after the Moderna Covid-19 vaccine and the flu shot) had not resolved.            No concomitant medications were reported. First dose on 16-Feb-2021 lot number 007M20A, second dose 6-Mar-2021 Lot No. 032M20A left Arm and first booster dose on 20-Nov-2021 Lot number 018F21A left arm. Patient did not know which arm he received the vaccine in. The patient went to see his physician and the physician sent him to the emergency room. Several tests were run on the patient and they all returned normal.     The patient reported that because he had been in bed for 5 weeks that must have received a bad batch of the Moderna Bivalent Vaccine.  No treatment information was provided.
1035 Complaints of throat itching and swollen tongue. Pt able to swallow and speak without difficulty.1036  Zyrtec 10 mg given PO. 1100 Pt stable discharged to home.
2 days after vaccination, pt noted swelling in upper arm (dependent to vaccine site) and swelling or R neck and jaw.  Temp 100.0 F x1day at 3 days post vaccine.  R neck, parotid, lymph node swelling persists 15 days post vaccination.
pinpoint sparse rash on extremities, trunk, face, states itchy, temp 97.2
The parents say she had fever, lethargy, lack of physical movement and activity, delayed speech development
2 and a half hours after vaccine: foggy mind and tiredness 7 hours after: flu-like symptoms, foggy mind, extreme tiredness, feverish, nausea, joint pain in knees, elbows, wrists Considering this the adverse event time frame: 24-36  hours after vaccine: fever, headache, joint pain, extreme exhaustion, loss of smell/taste, rapid heartbeat 48 hours after vaccine: slight headache, lingering tiredness, muted smell/taste, injection site swollen, red, hot, white center where needle was inserted.  It is a dried/not fluid filled white mark.
This case was reported by a healthcare professional via GSK representative and described the occurrence of bone pain in clavicular region in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX, and experienced bone pain in clavicular region and syringe issue. When the nurse was administering the TWINRIX to the subject, the nurse reported having more difficulty than usual depressing all of the vaccine out of the syringe while injecting the subject. At unknown time after vaccination with TWINRIX, the subject reported pain going up to her collar bone. At the time of reporting the outcome of the events were unspecified. No further information was provided.
sz 2 1/2 to 3 min duration;not eating or drinking well per report;no assoc fever-grand mal type sz & cyanosis;
MY Daughter received the "MIST" in the nose for seasonal influenza. Live, Intranasal Influenza Vaccine immediate clear runny nose, fever of 102 within 24 hours, dry cough within 24 hours.  fever lasted for less than 48 hours. runny nose continued with a cough for about one week.
This spontaneous prospective pregnancy report was received from a 28 year old female patient reporting on herself without medical history, drug reactions and allergies. On 23-FEB-2015 the patient was vaccinated accidentally with GARDASIL while she was 34 weeks and 5 days pregnant (dose, route of administration and lot # were not reported). The reporter stated that the incident did not happen at her primary care. Concomitant medications included unspecified medications. Patient's last menstrual period (LMP) was 25-JUN-2014 and estimated date of delivery (EDD) of 01-APR-2015. Initial exposure to GARDASIL was at 34 weeks and 5 day(s). The pregnancy outcome was outcome pending. Patient did not receive any treatment and there were no laboratory diagnostics studies performed. There were no symptoms reported. Additional information has been requested.
Extreme muscle and joint pain across the entire body for 2 weeks, post vax. Continued localized muscle pain in upper left leg and buttocks.
Low grade fever and loose stools on day of immunization prior to immunizations. Within 6 hrs of receiving immunizations, pt developed fever of 103-104 degrees F. and had generalized tonic/clonic seizure lasting 90 sec. On 01/12/2002 again, the pt had fever and generalized seizure. No history of seizures before 01/04/2002
Breakthrough case admission after 2 vaccines Janssen 4/11/21 Lot# 207A21A;  Janssen 1/13/22 Lot# 1855835
Symtoms appear 48h later: *Shortness of breath *headaches *low pressure *insomnia