chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, lethargy and extreme pain in arm where vaccine was administered, severe diarrhea and  nausea all occurred about 12 hours after first vaccination, lasted 12 hrs.  3days later, body started itching , felt like allergic reaction and had several red streaks and spots. Also started feeling so cold that I would shiver and my nose would run non stop. All would come and go. Only mild aches after second dose. Still having itching every day or 2. Also still get really cold with runny nose  and occasional sore throat. And both knees get very sore at times. My digestion has also not been right. I experienced none of these symptoms before the vaccine.
hardness at the injection site; the injection site was really red; the injection site was really raised; vomiting; nausea; I was achy; arm became sore; slept for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (the injection site was really red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination adverse reaction (Had reactions, similar to current vaccination ADR, after having a shingles vaccine a few months prior.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Mar-2021, the patient experienced PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised). On 27-Mar-2021, VOMITING (vomiting) and NAUSEA (nausea) had resolved. On 28-Mar-2021, PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised) had resolved.            Treatment was taken for the events with Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Sore arm; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included naratriptan (MANUFACTURER UNKNOWN) and birth control (unspecified); both for unknown indication from unknown date and unknown if ongoing. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN) and cefprozil (CEFZIL), for unknown indication on an unknown date and experienced drug allergy. On 13Mar2021 at 08:00, the patient experienced sore arm, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event sore arm, fatigue and chills was resolving at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
No adverse event; Interchange of vaccine products; This Non-valid spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.     On 02-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration and lot # were not reported) for prophylaxis.  Approximately on 16-SEP-2019 (reported as 2 weeks later), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, route of administration, lot # and indication were not reported) due to charting mistake (interchange of vaccine products). No adverse effects reported
PFIZER COVID VACCINE WAS GIVEN ON DAY 11 INSTEAD OF DAY 21.  PATIENT REPORTED MINOR ARM PAIN SIMILIAR TO FIRST SHOT
Experiencing a lump under her armpit; Swollen armpit; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 05Mar2021 at 12:30 (Batch/Lot number was not reported) (at the age of 59-years-old) as dose 1, single for covid-19 immunization. The patient did not had any medical history. There were no concomitant medications reported. There were no family medical history reported. There were no additional vaccines administered on same date of the Pfizer suspect.  There were no prior vaccinations within 4 weeks. On 09Mar2021, the patient experienced lump under her armpit, little swollen under the armpit under the arm she had her shot in. It doesn't hurt and it seems to be getting worse. The adverse event not required physician or ER visit. Patient wanted to know if this was normal. She was planning to receive the next dose on 26Mar2021. The outcome of event for swollen armpit was not resolved whereas, for other events it was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Shortness of breath; Lightheadedness. States it may be a panic attack . Cleared by ems.
This case was reported by a healthcare professional and described the occurrence of headache in a 41-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Past medical history included migraines. Concurrent medical conditions included hepatitis C. Concurrent medications included PREMARIN. On 7 December 2011 at 14:40 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm). On 7 December 2011, 20 minutes after vaccination with HAVRIX adult, the subject experienced headache. She thought she was having an allergic reaction and self administered ADRENALINE. The headache worsened and "after 15:00" the same day she began to vomit. She went to an emergency room and was treated with BENADRYL, ZOFRAN and liquid diet (clear liquid diet). She was not admitted to the hospital. At the time of reporting the vomiting resolved, the headache was improved and the outcome of possible allergic reaction was unspecified. The healthcare reporter assessed the event of headache as probably related to vaccination with HAVRIX and did not provide causality assessment for the events. Follow-up information was received on 4 January 2012 from the healthcare professional. The subject's medical history included bilateral saphingo-oophorectomy, renal stent placement and total abdominal hysterectomy. Concurrent medical conditions also included abstains from alcohol, previous anaphylactic reaction to an unknown allergen, anxiety disorder, cigarette smoker, cyst of kidney-acquired, hepatitis C, multiple drug allergies, post-traumatic stress disorder, pseudoseizures and recurrent kidney stone. Concurrent medications additionally included FLEXERIL, ZOLOFT, LAMICTAL, EXCEDRIN migraine and TOPAMAX. Upon follow-up the event possible allergic reaction was updated to anaphylaxis as the healthcare professional indicated that the subject had experienced anaphylaxis with hepatitis A vaccine. It was reported that the subject was prescribed ZOFRAN for nausea in the emergency room. The healthcare professional reported that the subject stated that "the injection" (not specified) also triggered a migraine headache. The vaccination course with HAVRIX was discontinued. The healthcare professional considered the event of headache as clinically significant (or requiring intervention). The events of headache, shaking, anaphylaxis and vomiting resolved on 8 December 2011. At the time of reporting the outcome of the additional events of nausea and migraine headache were unspecified. The healthcare professional considered the events of headache, shaking and anaphylaxis as probably related to vaccination with HAVRIX. The healthcare professional did not identify HAVRIX as a suspect product with vomiting. The healthcare professional considered the events of headache and shaking as probably related to Epi-pen and vomiting as possibly related to Epi-pen. Causality assessments for nausea and migraine headache were not reported. The healthcare professional reported that the event (s) may have also been associated with the subject's medical history of migraine headache, post-traumatic stress disorder and pseudoseizures.
Day  of shot 3-4 hours later arm started itching and was sore, did not sleep well that night. The next day just felt a little achy and chilled , arm at injection site red swollen and sore under arm by around 4 started to feel like running fever when got home from work around 5:30-6 pm took temp 101.9 hurt all over and nauseous took advil and fever finally broke was able to eat and felt better.  The next day went to work and appointment  arm more red and warm to touch and swollen under arm where shot given but as soon as I got home again my fever was 101.5 again took advil went to sleep fever broke during the night.  woke up Saturday morning congested and head stuffed up., little hoarse., ears stopped up.  Felt like I was drowning  but not a whole lot would come out when blew my nose. I stayed like this for about 4.5 weeks and then it just went away and have been fine since
about an hour afterward began experiencing diarrhea up to 6 times that day. around 11:30PM at work I began feeling a whole body tingling/pins and needles sensation along with muscle/joint pain in my back, neck, and hands. The tingling lasted about 3 hours then subsided, on the 19th night again I felt the tingling for about an hour.  patient replied yes, she had MIS as result of Covid vaccine.
Pt was unable to provide the information that he was previously vaccinated.  The patient is homeless as well and was being transferred to another facility.  The facility required the covid vaccine for placement.  The patient was able to sign his name to accept receipt of the vaccine.  Upon entering the vaccination into database it was determined he had already received the completed series.  The patient was monitored for adverse events after the injection and the following subsequent days.  No adverse event was reported by providers.
Patient reports waking up on 8/22/21 with loss of taste and smell, then developed diarrhea, sore throat, fatigue, headache, and nasal congestion. Patient did not have a known exposure. The patient will be receiving an infusion of casirivimab/imdevimab (Regeneron) on 8/25/21 as an outpatient.
Patient is complaining of moderate to severe pain and soreness in left arm. There are 2 puncture wounds that are red and scabby where she says the shot was administered.
developed hives on his back 2 days later; stomachache; felt weak; headache; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who developed hives on his back 2 days later, stomachache, felt weak and headache after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2023, the patient received unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactical vaccination (Immunization). Information on the batch number was requested.  On an unknown date the patient developed events of hives on his back 2 days later (urticaria), stomachache (abdominal pain upper), felt weak (asthenia) and headache (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was reported that "Caller is asking if this is ca common occurrence with this vaccine or if others have experienced the same reactions. Notified the caller that we would not be able to see other reports for MENQUADFI patients, but we could report the issue to the manufacturer."  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.    At time of reporting, the outcome was Unknown for all the events.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment taken was Paxlovid from 15Nov2022 to 19Nov2022. Still testing positive 13 days after onset of COVID. Symptoms left is dry throat on day 13. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient developed headache and arm pain day after vaccination. Patient stayed and worked from home on this day as a result.
Patient develop soreness around the area of vaccine and has been unable to raise her arm. She was seem by her physician who advised her to keep applying heat and massaging the area. Neurologist visit may be recommended if condition does not improve.
Patient became weak and lightheaded. I found him pale, diaphoretic and tachypneic. He reported, "This always happens when I get a shot. I just need some sugar like juice." He denied difficulty breathing or chest pain. He was not nauseous nor did he vomit. I transported him to a private holding room via wheelchair and gave him a 12 oz can of Coca-Cola. He took sips and immediately reported feeling better. The initial vital signs I took were as follows: Temp 98.6 F, HR 67, BP 84/48 mmHg, RR 24/min, and SpO2 97%.  After recheck in 15 min BP improved to 106/62 mmHg, his became more pink and no more diaphoresis. I observed him for 30 minutes total and he was stable to go home. He drove himself home.
4/19/07 Shot administered approximately 9:00am, no reaction at office. 3pm Patient returned to office, c/o erythema, swelling and pain at injection site approximately 20cm. Patient given Zyrtec 10mg. Patient took Benadryl at home.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old female who received FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 06-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2009. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that the expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Pt received Pfizer for first dose and moderna for second dose. No adverse affects were observed.
I had recently weaned from breastfeeding and had not had milk for approximately 3 weeks. After the first dose of Pfizer I experienced relactation. My milk came in as if I had just given birth. I was engorged for 5 days before it subsided.
On the same day, the patient received Pentacel and ActHIB vaccines; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 29-Apr-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI9128A via intramuscular route in the left vastus lateralis.  On 29-Apr-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ066AB via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to Extra dose administered.  It was unknown if any adverse event was 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.  Documents held by sender: none.
Bandaid scar where the shot was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on an unknown date (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to powdered latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient had a bandaid scar where the shot was administered and it was been there since she had taken the shot and the scar was still on her arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bandaid scar where the shot was administered was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician's office concerning a less than 1 year old female whose 7 year old white brother was vaccinated IM with a first dose of varicella virus vaccine live. It was noted that the female contracted chickenpox. The reporter indicated that the brother also developed chickenpox. No further information is expected.
HEADACHE; bones are aching; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Shingrix and TETANUS VACCINE. On 14th May 2019, 1 days after receiving Shingrix, the patient experienced headache, bone pain and influenza-like symptoms. On an unknown date, the outcome of the headache, bone pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache, bone pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: On the reporting date, in the morning, the patient experienced headache, his bones were aching and he had flu like symptoms. The reporter did not consent to follow up.
Fever and chills starting 24 hours after injection, lasted ~6 hours General achiness/soreness, fatigue, started 24 hours after injection, lasted ~2 days Redness and minor swelling at injection site, lasted ~1 week Swollen lymph node above left clavicle, started ~48 hours after injection, lasted ~3 days
Upper arm became inflamed, itchy, hot for approximately 4 days, then gradually subsided
pt recv vax & became pale & diaphoretic, then appeared to stiffen w/rt facial twitching lasting 15-30sec;then appeared focused, became limp, skin pale, diaphoretic & unresponsive for 60 sec;appeared apprehensive;pt appeared to have fainted
pt recv vax 9APR98 & APR98 exp bilat leg pain & also found to have hypereosinophilia;pt hosp
Redness and soreness on 9/22/14. Awoke on 9/23/14 was hot, swollen, and little itchy. Showed nurses 9/23/14 afternoon. Put ice pack to site and soaked in bath 9/23/14 evening. On 9/24/14, redness decreased and more itchy. Nurse measured 93mm hard induration at injection site on 9/23/14 at 14:40.
Began having vague fatigue and nausea 8/21/19. Fever up to 102F began 8/23/19. Seen in urgent care 8/25/19. Sore throat, no rhinorrhea, cough or congestion. No sick contacts. No other members of family ill. CBC WNL.
I had a headache that just wouldn't go away and I was a little nauseous. I was an event with my daughter at the civic center and I passed out. I had to be transported by ambulance to the E.R. This lasted about 4 days. It's still hard to catch my breath at times.
Patient experienced.  Severe swelling with red welt from injection site to mid fore arm. Severe pain.