chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain throughout the body; Muscle aches; Headache/ inability to touch her head due to sensitivity/head cramps; Temperature began to rise; Cramps to her earlobes; Pain at left arm; Felt electric shock pain in bilateral ears; Had to walk in a stooped position; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PAIN (Pain throughout the body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient did not have any acute or chronic long standing health conditions at the time of vaccination.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.   On 23-Mar-2021 at 4:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears) and GAIT DISTURBANCE (Had to walk in a stooped position). 21-Apr-2021, the patient experienced HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps). 21-Apr-2021, the patient experienced PYREXIA (Temperature began to rise). On 24-Apr-2021, the patient experienced MYALGIA (Muscle aches). On 24-Apr-2021 at 8:00 AM, the patient experienced PAIN (Pain throughout the body). On 25-Apr-2021, PAIN (Pain throughout the body), MYALGIA (Muscle aches) and HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps) had resolved. At the time of the report, MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PYREXIA (Temperature began to rise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 - 103 (High) High.         . No treatment information was provided.    This case was linked to MOD-2021-059509 (Patient Link).
Local soreness developed within 2 hours; General whole body achy feeling developed within 8 hours; The achy feeling is less pronounced today (the next day), but local soreness in my arm is about the same.
i tasted the shot when it kicked in around midnight on 6/13/21.  after that i began feeling nausious and extremely tired and my head, neck, and lower back began to really hurt.  I was at work when this occurred.  I got off work at 7:30 am and went home and went through hot and cold flashes, throwing up, migraines, body ached all over, and it felt like i had phlemph stuck in my throat.  i still am not feeling well and the headaches are coming and going and hot and cold flashes.  I am keeping down water at this point.  the body aches are mostly occurring at night now.
After recieving Tdap and HPV4 vaccines, patient stood to leave and became pale and began to fall. She was assisted to a sitting position and aroused with an ammonia capsule.  She stated she felt nauseous and hot. She was assisted to a lying position with feet elevated. B/P was 98/52 Pulse was 66.  Cool compress applied. After 10 minutes B/P was 100/60.  Juice was offered.  After 10 minutes B/P/ 100/64.  Pt assisted to personel vehicle by mother and clinic RN.
a little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included PROBIOTICS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (a little tiredness). At the time of the report, FATIGUE (a little tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication was reported.   This case was linked to MOD-2021-297572 (Patient Link).
DT shot 7/21/03 in a.m. no reaction noted on Monday, Tuesday complaint arm just sore, Weds. said arm very red, sore (hard as rock), warm to touch. 4.5cm long and 4cm wide redness.
At 5:30pm on Jan. 8, when the patient stood, she had a sudden wave of nausea and started to feel faint. She had to lay down on the floor immediately to avoid losing consciousness. For the next 2 hours, she experienced nausea and faintness when standing for more than 30 seconds. After those 2 hours she no longer experienced these symptoms, and she developed a fever and flu-like symptoms for 36 hours.
CUSTOMER INFORMED PHARMACY THAT HER ANKLE HAS SWOLLEN UP THE DAY AFTER THE FLU SHOT.
On Thursday, 7/1/21, patient received her second dose of Pfizer Covid-19 vaccine (LOT #: EW0191, exp: on 8/2021) at 12:04 pm on her left deltoid. During assessment questions, client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. Client stated she takes Captopril when needed however has not taken any medication for two years. At 12:10 pm, while waiting in Observation Area, client stated to RNs, she is feeling "dizzy for a moment and a tingling sensation in left arm." Client also stated she was "feeling nervous at beginning of vaccine" and was also nervous when she received four other vaccines 10 days prior. Those vaccines were: TB, Tetanus, Hepatitis & Flu with no allergic reaction at the time. At 12:12pm, client was seated with anti-gravity and vitals were started and taken every 5 minutes. Client was also given a bottle of water and offered Benadryl to which the client denied. At 12:12pm, BP: 148/74, HR: 88, O2 sat: 98%. At 12:17pm, BP: 162/78, HR: 84, O2 sat: 98%. At 12:25pm, BP: 170/93, HR: 94, O2 sat: 98%. At 12:40 pm, BP: 152/87, HR: 88, O2: 98%. At this time, client told RN she was no longer dizzy or experiencing any tingling sensation. No further interventions needed. Client was educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 12:50 pm and was driven home by a relative.
Information has been received from a physician concerning a 17 year old female who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient developed pre-syncopal episodes were unspecified. The patient was referred to a neurologist. Additional information has been requested.
I started to notice hives when I woke up that covered my whole body. My body was swollen. I went to urgent care and they thought it could be eczema. I went to a dermatologist and it was urticaria. I now take 4 Zyrtec and 2 Pepcid daily to control the hives on my body. It seems to be working but if I do not take my medication on a daily basis, I will be covered in hives again. I am not going to go to an allergist to see if it is due to the vaccine. I have been told by my dermatologist that it was very possible that it is due to the vaccine.
Presented to Dr office 9/21 w/ complaints of headache, N/V/D. started a week ago after second covid vaccine. No fever or cough. BP 118/79;  Pulse 86;  Temp 36.5 °C. Given Zofran prescription.
I noticed pain and swelling in my left armpit about 24+ hours after receiving the booster vaccine for COVID-19. Swelling is about half a baseball size, but the whole general armpit area is tender.
This child had been eating normally, never cried, ate normally, and never vomited.  Four hours after the injection, her appetite was voracious.  After eating more than ever before, she vomited violently.  She began nonstop, inconsolable crying.  Her eating became irregular from then on.  She cried for 12 straight days.  She would fall asleep in the middle of a yell, and wake up yelling again.  No consoling techniques helped.  After 12 days she experienced short periods of not crying.  That situation became the norm.  She did not show any of her pre-injection happiness until 6 months later, age 7 months.  Her eating did not return to normal for well over a month.  Her fraternal twin sister experienced the same symptoms to a lesser degree.  Her eating pattern was disrupted the same way, but returned to normal after a few weeks.  She cried for three days straight, but showed happiness again after a few weeks.
regular, repeating prolonged bouts of fatigue, difficulty breathing, loss of appetite, respiratory infection and cold-like symptoms
pt recv comvax & hep b instead of ped hib & hep b vax; there was product confusion;pt sought unspecified medical treatment;
COVID Vaccine Clinic. Upon staff member receiving second dose of vaccination, Team took staff member back to vestibule area for injection (proactive)due to previous reaction to first dose. Staff member was positioned supine on cart for injection.  Within 5 minutes, staff member felt dizzy and became nauseated. Blood pressure 119/81 HR 90.Po2 at 100% on room air. Still complained of feeling faint and dizzy. Staff member remained supine and was monitored until symptoms subsided. 1550 Staff member was feeling much better. Symptoms gone per staff member.  Staff member ambulated independently without dizziness.  Staff member went home with husband in stable condition.  Staff member encouraged to contact PCP for any further concerns.   Staff member was evaluated in ED.  fluids given, Zofran for nausea and Benadryl.  CTOH was completed and resulted as no abnormalities.  Staff member was discharged to home in stable condition.
My thyroid condition ramped way up. My heart was in constant flutter for three days. My body temperature was all over the place. I lost 7 pounds in 48 hrs. I couldn?t sleep for three days. These are common symptoms of my thyroid acting up but it was extreme. Even for when it does this. It went away after three days but still hasn?t returned to normal.
Soreness, several hours after the shot and lasting about 3-4 days, felt like a major bruise, but went away.  Then, 7 days after the vax, started itching in the area of the injection site, which subsided with a Bendadryl overnight and next day.  In the evening of the 8th day after injection, began itching again and noticed large red patch, slightly swollen and a little warm.  Itching is mild, goes away with cortisone cream.
The 16 yo child described muscle twitching all over following vaccination (7pm same day). The mother took her to Hospital ER. They ran tests, which showed that nothing was wrong. The twitching was not witnessed in ER. The next day child experienced flu-like  symptoms and stayed home from school. The day after 9-30-9 felt fine & returned to school, has not complained of any further muscle twitching.
feeling like she "was seeing stars but not passing out" Lightheaded; the patient began to experience shaky; This is a spontaneous report from a non contactable other healthcare professional. A 20-year-old female patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; lot number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication details were not provided. On 19Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience shaky, feeling like she was seeing stars but not passing out - Lightheaded. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. It was reported that the treatment included: water and snacks and follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with PCP (primary care physician). The clinical outcome of the events feeling shaky and light headedness was unknown.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality in reporter tab was unticked. Patient name updated since First Name and Last Name should be captured separately.
Patient began to feel light-headed 5 to 10 minutes after receiving vaccination, then eyes closed and she fainted, staff brought her to a lying position on floor with knees raised and she regained consciousness but felt nauseous. A family member came to take her home around 30 to 40 minutes later.  She left feeling nauseous.
Sore arm, sensitive teeth in multiple locations to cold drinks and air- back left top teeth and behind front teeth
A nurse reported that a male pt received an injection of Pnu-Imune 23 and influenza virus vaccines on 10/14/99. That evening, he developed pain and swelling at the injection site so severe that he could not lift his arm. The next day, he developed nausea and a headache. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune lot 459038. The pt's wife experienced this event following receipt of vaccine administration on 10/14/99. See MCN HQ8085310DEC1999.
Lump at injection site.  Sore shoulder with limited use of upper arm muscle. Headaches.Sensitive stomach. Tired.
Horrible Terrible pain in my muscles, joints, hands, neck, shoulders, arms.  I tried Motrin, Tylenol, VICODIN, every 4 hours.  NOTHING worked to abate the hideous, throbbing pain.  This went on 5 days.  Still today, my neck, shoulder, arm & hand hurt (right side).  There is a 3"x3" raised, red, tender, hot circle at the injection site.  Impossible to sleep my neck & shoulders hurt so much. It is a little less today, but not gone, still painful.
Information has been received from a female registered nurse of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the nurse was preparing a dose of ZOSTAVAX (dose, lot # and expiration date not reported), and when she was withdrawing reconstituted ZOSTAVAX, very small droplet squirted out and got onto her face near her left eye. ZOSTAVAX droplet did not get into the eye. The nurse immediately washed the area with soap and water. No adverse effects were reported. Follow-up information was received on 18-JAN-2017 from the registered nurse. The nurse reported that on an unknown date, the incident was a splash to the face/eye area while preparing ZOSTAVAX for intramuscular administration. The nurse was tested for varicella titre (results not provided). Additional information has been requested.
persistent crying 2nd day p/shot;irritability, dec sleep-48hr p/shot
VOMITTING, NASEAUA, HAEDACHES, DEHYDARTION, IRRREGULAR MENSTRUAL BLEEDING, LOSS OF APPETITE, EXHAUSTION ,STOMACH PAIN, EXTREME CRAMPS, BACKPAIN , AND  STIFF MUSCLES
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  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 guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
7-8 days after Pfizer #2 I started to have severe fatigue, and recurrent hot and cold spells accompanied by arrythmia.  Exercise intolerance and leg/nerve pain after mild activity (walking dog around the block for 15 minutes).  Suppressed appetite.
Heart palpitations, tachycardia, PVCs  and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.
Pt was vaccinated in 1996 and approximately 3 years post vax sought medical attention for varicella exposure. A serum VZV antibody test revealed negative titers. No further information is available.
Itching behind ears/scalp.  Fine rash on forehead started in a.m.  Late p.m. became irritable, mother gave benadryl but symptoms not relieved.  Taking child to MD the following day.
It wasn't to awfully severe but within 2 minutes of having it I got very dizzy light headed< I couldn't shake it I laid down for about an hour and I was okay to drive again. It felt like I had a drink or it lowered my blood sugar.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 68 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI980AA and expiry date: 30-Sep-2019) (dose in series and route of administration were not reported) in the left deltoid on 05-Sep-2018 instead of FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. Patient wanted to know how he should get high dose and should he be re-vaccinated. Pharmacist wanted to know if there would be a High Dose with 4 antigens. It was unknown if any adverse event was occurred or not following the vaccination. 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 the sender: none.
Received vaccine at 1649, had syncopal episode at 1650. Positioned patient in a recumbent position. Vital signs stable. Given apple juice and observed. Patient disposed to home.
Tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Flare up of arthritis and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement, ASCORBIC ACID (VITAMIN C ACID) and ZINC for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Tiredness). In March 2021, FATIGUE (Tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included tonic water. Treatment information included antihistamines, Zyrtec 10 mg and ice pack.   This case was linked to MOD-2021-214321, MOD-2021-214321 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant follow up received on 15-JUL-2021. Concomitant medications and medical history updated.
dose was given prior to vial being mixed, no adverse events at present parents to monitor and present to ED if any adverse events
Information has been received from an office receptionist concerning her 12 month old daughter with asthma who on 13-NOV-2006 was vaccinated with MMR II. The child developed a spot on her back shortly afterward. On 21-NOV-2006, the female was given by her mother a 4 mg oral granule sample of montelukast sodium (MSD) for asthma. It was reported that the child's rash seemed to increase to spots all over her entire body. The physician in this case was not the patient's physician and felt the rash was not related to montelukast but rather the MMR II administered on 13-NOV-2006. This physician advised that montelukast therapy be discontinued immediately. Patient outcome was unknown. Additional information is not expected. Unspecified medical attention was sought.
6 days after shot,   a rash, itching and black and blue mark appeared on left arm at site of injection. started on day 6 and still present on day 7.
Red rash With irregular border at injection site. Hot and firm to touch. Appeared 4-5 days after vaccination.
Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 in 2020 wherein the reporter and the patient had it last year. The patient's concomitant medications were not reported. The patient experienced fever with outcome of recovering. She already took TYLENOL to treat her fever. It was queried if the patient can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient was a nurse, she got the Pfizer vaccine yesterday on 21Jan2021, that at 3am this morning (22Jan2021), she had a 101 degree temperature, a 100 degree temperature at 8AM and a while ago it was 99.9 degrees at around 9:30 this morning. The reporter wanted to known if these were expected and what they should do. The reporter mentioned that his wife's case was not so bad, states that he himself was in the unit for some weeks. The patient also had fatigue 22Jan2021 with outcome of not recovered.  Information about Lot/Batch has been requested.