chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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 medical assistant concerning a 9 year old female, weight 78lb, height 58 inches, with attention deficit/hyperactivity disorder (ADHD) and no history of drug reactions or allergies who on 22-MAY-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot#: 660042/1899U) 0.5 ml subcutaneously in the right arm and HAVRIX (lot#: AHAVB268EA) in the left arm. Concomitant therapy included CONCERTA. On 02-JUN-2008 the patient experienced a rash. She was seen in the office on 03-JUN-2008 with 6-8 vesicles at the injection site on her upper right arm spreading toward her elbow, her temperature was 99.4 F. The patient was diagnosed with chicken pox. The patient was treated with BENADRYL if needed for itching. Subsequently, the patient recovered. Additional information is not expected.
Patient got MMR #1, VARICELLA #1, DTAP#4 , PRENVAR#4 + HIB#4. after 10 minutes, mom noted redness ~ the night of the MMR, a few minutes later, became a hive with 1 inch diameter redness stated on the Varicella site too, hot mild.
1/14/21- 10:30am Noticed some fullness/swelling in throat. Was still able to breath fine, but definitely noticed a difference. This lasted a few hours.  1/15/21- 3:45am I got up to use bathroom and noticed I was very lightheaded. I thought maybe I just stood up too fast. I got back in bed and my arm was 8/10 pain so I also thought faintness could possibly due to pain.  7:15am I got up to go to work and quickly felt very warm and my vision started to go black. I laid back down for a few minutes until this resolved. I took my temperature and it was 99.0. I got up again and started to get ready but began feeling light headed again. I ended up getting ready while sitting down because I kept feeling too much like I was going to pass out. I ate breakfast and felt fine. 8:00am I left for work and after driving for about 5 minutes I felt myself getting very warm again and light-headed. I ended up pulling over and calling for someone to come pick me up.  9:00am My temperature was 99.5. My blood pressure laying down was 110/74 and HR was 74. After standing for 5 minutes my BP was 90/70 and my HR was 92. During this 5 minutes of standing I felt myself getting warm again but my vision did not start to go black and I was able to stand for the full 5 minutes.  At various times throughout the day I would feel faint if I was standing or sitting upright for too long. The last time I felt this was was probably 11:30pm on 1/15/21. 1/16/21 - No light-headedness or warmth. Did feel some slight chest pressure, but nothing crazy and it only lasted maybe half of the day.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 7:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 7:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown if patient had acute illnesses and chronic and long standing health conditions. Patient took booster dose.  A series of patients approximately 540 patients received lot number 066H71A past its 30 days expired date. Vaccine was administered up until its Manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
Patient states infection at site of PNEUMOVAX - physician treated with BACTRIM & naproxen (shot given 10-13-10 saw MD 10-18-10).
Injection at 15:00 by 17:00 dull pain up arm to neck with headache by next AM, patient so weak she could not move also pain to entire body, taken to ER.
Achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (in remission 2 to 2 1/2 years).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy) and CHILLS (Chills). At the time of the report, PAIN (Achy) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax & 5-6min p/vax pt couldn't see well & felt weak then fainted for 3 seconds;BP 90/60, p96, repeat BP 92/62, p 80;pt doing fine p/15min;
The pt received dose 2 of the Pfizer Covid-19 vaccine on 7/26/21. The pt developed diffuse body aches the day after the vaccine which included chest pain. The second day after the vaccine his body aches were improving except for the chest pain which was progressively worsening which prompted presentation to medical care. Hospital course from discharge summary: Patient was admitted for management of myocarditis/pericarditis, presumed to be secondary to Covid immunization.  On presentation, his troponin was 21.98 ng/mL with a low normal EF of 52% on formal echo at presentation on 7/29.  Troponin peaked at 46.10 ng/mL on the evening of 7/29.  Cardiology was consulted who provided recommendations throughout admission.  He received 2 g/kg of IVIG, divided over 2 days 7/29?7/30.  He was put on scheduled Toradol and received IV methylprednisolone while admitted.  Echo normalized on 7/30. He was monitored on telemetry without any significant pain or abnormal rhythm changes in the 1-2 days prior to discharge. He was discharged home on oral steroids and scheduled ibuprofen until follow up with pediatric cardiology on 8/5. Patient and his mother received strict return precautions for return to care and were in agreement with the plan."
Vaccine expired on 2/12/23 and was administered on 2/13/23
Nose bleed; Light Fever; Tiredness; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. 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 orphenadrine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 18Apr2021 at 11:30, the patient experienced light fever, tiredness, headaches 3 days including day of vaccine. On 20Apr2021, the patient had nose bleed between 48 and 72 hours of vaccine application. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light fever, tiredness, headaches and nose bleed were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, SkinRash, ErythemaMultiform, Fatigue Narrative: Employee reports she experienced body aches, swelling at injection site, and redness/warmth at injection site. All have improved except the redness/warmth at injection site.
"Rt arm swelled elbow to fingers-no feeling & cannot move fingers"; 03AUG92 seen by MD "visible nontender swelling & pain, neuro intact-pain on extension-site unremarkable-arthritic rxn"; recom Ibuprofen; no further MMR;
Patient stated that she had the normal side effects. She also had non controllable movements. She had abnormal posturing that lasted for about five hours.
pt reported that 10 days after vaccine she had a delayed reaction of itching, swelling, a knot, and feeling warm in where the injection was given.  She also reported  neck pain.
A couple days following the booster vaccine developed a numb tongue and by 12/17/2021 developed face paralysis on the right side of face.
COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 (dose number in series 2). Reporter stated that, "The shots we were told to prevent covid. They lied. I still got it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263899.
A report was received on 11/17/03 from a health care professional concerning an unspecified number (approximately 20) of vaccinees who inadvertently received 1ml Fluvirin on 11/17/03. On 11/17/03, an unspecified number (approximately 20) of vaccinees inadvertently received 1ml Fluvirin. The vaccinees did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Day after 1st dose, headache, fever 102.3, severe muscle aches, sever joint aches, nausea, sore left arm with hard lump 2 inches wide, lymph nodes swollen in left arm pit, exhaustion, dizziness  Day 2, headache, muscle aches, joint aches, fever 101.3
Face swelling, severe congestion, tightness of lungs. Body ache. Going on 4 weeks of this. 2 er visits
Sleeplessness the night of vaccination, following day not able to get out of bed, slight headache, total ?brain fog?, trouble putting sentences together, memory impaired, redness and pain at injection site. Lasting approx 48 hours and improving slowly after.
Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 4-Aug-2023 The pharmacist stated that the patient was at the pharmacy to get the 2nd dose at the time of the call. The exact date of first date was unknown as it was administered at a different facility. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
chills; light headed; sore arm; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, CHILLS (chills), DIZZINESS (light headed) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were provided.    This case was linked to MOD-2021-034965 (Patient Link).
Patient was given her second dose of Pediatric Pfizer after only 13 days, rather than 21.  Was realized when we went in to chart it.  Spoke with my supervisor and was told to report immediately.
Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in ER after 24 hours of symptoms.  Fatigue for 1 week post vaccination.
Pt recvd vax 6OCT92 & later that day devel itching @ the inject site, sore arms, fatigue, fever; 7OCT92 felt exhausted & achy all over w/generalized muscle aches, sinus infection; felt like a worsening chronic fatigue synd;
headache; This is an initial spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) reported. A female patient with an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient had first shot of vaccine. She said had a headache, but that it could be just allergies. Want to know if she can take aspirin (Excedrin). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 2 month old female with gastroesophageal reflux, allergic colitis and protein allergy (milk), who on 20-SEP-2007, received a first time 2.0ml oral dose of Rotateq (lot# 657522/0769U). Concomitant vaccinations included Pediarix, Prevnar, and Pedvax HIB generic (manufacturer unknown). Concomitant therapy included lansoprazole (PREVACID). She developed vomiting, fever, and diarrhea and was hospitalized on 26-SEP-2007, with a diagnosis of rotavirus. Diagnostics, treatment, and current patient status were not reported. A product quality complaint was not reported. No further information was available. Rotavirus was considered to be life threatening by the reporter, as the patient was dehydrated. A lot check was requested. Additional information has been requested.
little chills; fatigue; right arm pain, left arm pain; light fever (99.7); This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. On 27Jan2021, the patient experienced little chills, light fever 99.7 (unknown unit), right arm pain and then her left arm was painful, and fatigue. The patient wanted to know if this was normal. The clinical outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Initial report received on 16 March 2010 for the above-mentioned trial. This report was received from a phase II trial with investigational product MONOVALENT FLU A/H1N1 PRESERVATIVE or FLUZONE SV 2009-2010 or PLACEBO for which sanofi pasteur is not the sponsor. SAE Term: Hospitalization for Abdominal Pain. Onset Date: 22 January 2010. Causality: Not Provided. Serious Criteria: Hospitalization/Prolonged Hospitalization. Documents held by sender: None.
States had vaccin 1/22/21, did okay initially, felt thirsty , drank coffee afterwards and felt better, went home after, had some "shimmery vision - like things see brighter which is slightly better, also felt body buzzing - which resolved,  hands are shaky which is persisting (as of 1/25/21) ; no thrt closing or resp sx,
3/15 Vaccine- 2:40pm 3:00pm- headache  3:30pm- headache, sore throat and chills 8:30pm- chills, fever of 103.1, muscle ache, sore throat, nausea  3/16 Early morning- throat and mouth swelling, ear ache, sore throat, chills, headache, exhaustion  Prescribed Prednisone to take down swelling in throat and mouth- swelling came down   3/17 Sore throat, headache, exhaustion and fatigue   3/18 Sore throat, cough, exhaustion and fatigue  3/19 Early morning- sore throat, nausea and fever of 100.7
Headache, fever of 101.2, body aches, chills, fatigue. Lasted one day.
Chills, upset stomach, tiredness and fever 101.1 to  102° starting at 2:30 am April 15 until 12:30 am April 16th.
Morbiliform rash- MMR rxn; non itchy rash on body; recvd MMR vax 7 days ago; No resp distress, no fever; no tx required;
Delayed ovulation 7 days and then spotting before next cycle.  I have tracked this for natural family planning for 20 years.  I can tell the difference.  Still seeing more spotting 3 cycles later despite usual progesterone supplements.
Systemic: Chest Tightness/Heaviness/Pain-Medium, Systemic: Tachycardia-Medium.
Patient is out sick today and missed the second dose with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was out sick today and missed the second dose with no reported adverse event for rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Illness.  On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine Powder and solvent for suspension for injection (with an unknown dosage, lot number, strength, expiry date) via unknown route in unknown administration site for Immunization.  On 05-May-2023 the patient developed a non-serious event of patient is out sick today and missed the second dose with no reported adverse event (product dose omission issue) (unknown latency) for rabies (HDC) vaccine  Reportedly, Caller stated that she has patient that was due for second dose of IMOVAX. She thinks this would be booster doses for patient but is unsure. Patient is out sick today and missed the second dose. Caller stated the patient can come in next week to get dose, but caller wanted to know will they need an additional dose due to them missing second dose in the 7-day window period.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
First started as dizziness, followed by localized severe headache, followed by runny nose and itchy eyes and slight cough.  A few hours later, felt tired so went to bed.  24 hours after the shot, injection site was hard, raised, hot, and itchy.  48 hours after the shot, injection site was still hard, raised, hot, and itchy, and coverage area had more than doubled. 71 hours after the shot, injection site has same symptoms, though they are beginning to diminish.  Size of affected area is now about 4 inches in diameter.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. On 21-JUL-2016, 04-AUG-2016 and 17-AUG-2016, the multiple unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot # L048854, expiry:31-AUG-2017) orally. No adverse effects were reported. The vaccines underwent temperature excursion on 18-JUL-2106 at 48.37 degree F for 48 hours, on 19-AUG-2016 at 34.16 Degree F for 24 hours and on 22-AUG-2016 at 53.16 degree F for 48 hours. Additional information has been requested.
PT FAINTED ABOUT 10 MINUTES AFTER VACCINE WAS ADINISTERED, FELL FORWARD FROM SEATED, HIT HEAD ON GROUND, HUSBAND CALLED EMT, PARAMEDICS ARRIVED TO TAKE PT TO EMERGENCY ROOM, PT HAD SUFFERED FROM POSSIBLE SEIZURE AND CONCUSSION
Rash developed on R upper thigh. 8 red itchy bumps. Have lasted at least 4 hours, still observing