chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot at 12:00 pm Fell asleep in the car (very unusual) Screamed awake at 12:36 pm  He was arching and screaming like he was pained and confused. He has only screamed like this after getting ear tubes placed and coming off anesthesia. Post surgery scream lasted less than 15 minutes. Fell asleep mid scream in my arms at 2:28 Sleepy cries and whimpers for entire nap Woke at 3:48 pm screaming and pooping diarrhea  Stopped screaming when his dad got home (5:14?) Motrin at 7:00 pm Slept 7:18-9:23 pm Up and down most of the night and the next day arching, whimpering, screaming.  6:35-6:48am staring not moving   I called the advice nurse line and was told not to bring him in because screaming in pain was normal. I regret this and wish I had sought a doctor?s examination.
the vial was initially stored in the refrigerator and administered past the 30 day use by date; no adverse event; they inadvertently administered a dose from a vial which was past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date).    No concomitant medications were reported. No treatment medications were reported.  The vial size was of 5.5 ml. The beyond use date written on the vial was 01-Oct-2022. The vial did not undergo any temperature excursions.
High temperature, high-pitched screaming and bruising on legs. Dx: hemolytic anemia/thrombocytopenia.
For the last 2 months I have been exhausted. I barely have enough energy to go to the bathroom. I can sleep for 18 hours at a time. I have been suffering from chronic fatigue. If I have to go out for the day, I have to sleep the entire next day.  I am still dealing with this at this time.
The evening after getting my vaccine I had a sharp pain behind my right ear and severe headache but did not get concerned thinking it was just a common side effect. On Wednesday the 19th I felt tired and had a headache most of the day but still didn't feel there was anything to be concerned about. On the evening of the 20th while eating with friends they noticed my eyelid drooping and the corner of my mouth also drooping and my speech becoming slurred. Our guest included a retired Nurse anesthesiologist who suggest I get medical treatment right away. I went to Convenient care who sent me to the emergency room.  I was told I had developed Bell Palsy and it could have been part of a reaction to my Pneumonia vaccination.
Patient tested positive for COVID 9/29/21. Patient previously fully vaccinated. Presented to ED on 10/5/21 with worsening symptoms  of confusion, cough, shortness of breath, decreased appetite and nausea.  Patient diagnosed with COVID pneumonia. On arrival to the emergency department patient's initial blood pressure was 74/53.  Patient was taken and IV line and fluids was initiated.  Is currently maintaining an oxygen saturation of 92% on room air. Patient discharged in stable condition.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-APR-2015, the patient was vaccinated with improperly stored M-M-R II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
father states pt woke up sat AM w/fever 102.0 & c/o being achy all over;Sunday fever rose to 103.0;has been giving APAP which helped very minimally;called walk-in to bring in if fever one more day;Monday feeling better;
body aches (extreme), extreme fatigue so that I slept about 32 hours, temp of 101.1, diarrhea, headache
Redness and pain at injection site for four weeks. Was caused by the broken tip of the needle. Started antibiotics Feb 2nd, 2010.
Patient received vaccination on 10/10/07 had redness and swelling on 10/11/07 and saw her ENT. Her ENT told her that if it got worse she would need to call doctor on 10/12/07 we referred her to ER.
Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------
Initial unsolicited report received from a non-healthcare professional (medical assistant) on 10 July 2015. That report is from a Partner and contact information in based upon the location of our trading partner. A female patient (age not reported), whose medical history was none and concomitant medication was not reported, had received a dose of ADACEL (batch number: U4971AA, expiration date: 14 February 2017, dose and dose number were not reported) intramuscularly in left deltoid on 2 July 2015. On an unspecified date post-vaccination, the patient experienced arm pain with limited range of motion. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. The patient required ER/doctor visit. Laboratory investigation was not reported. The patient had received Ibuprofen as a corrective treatment, which was provided some relief of pain until the medication wears off. As of 10 July 2015, the patient was not recovered from event. List of documents held by sender: none.
High dose vaccine was given to 62 year old discovered after administration. No adverse affects reported by patient.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 76-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date after receiving the second dose of the Pfizer COVID-19 vaccine, patient experienced pain at injection site. It was very bad. She couldn't raise her arm until today. She also had fatigue, muscle pain, chills and swollen lymph nodes in her neck. Last night it was pretty bad. It took her until midday to feel a little bit better. Patient stated she did not receive any paperwork including the recipient fact sheet, so she did not know what to expect. Patient wanted to know if these symptoms were common after receiving the second dose of the Pfizer COVID-19 vaccine and how long these symptoms would last. Patient also mentioned when she was speaking to the agent prior to disconnection, she was told more people have reported side effects after the second dose than the first dose. She wanted to know if that information was true. Investigation assessment: no. Therapeutic measures: not taken. The outcome of events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
had pain at injection site; fatigue; This is a spontaneous report from a non contactable consumer. This consumer (sister of patients mother) reported for a 17-year-old female patient. A 17-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, The patient had pain at injection site and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt recvd 1st dose of Hep B vax & devel severe case of herpes simplex all over lips & mucous membranes lining mouth;
sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymph nodes enlarged.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE PAIN (sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR was Added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medication was reported. This case pertains to the 59th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
RASH FORMED FROM KNEES TO HIP. MAYBE A LITTLE ON CHEST/BREAST. RED AND WELTY. HIVE-LIKE. BUT DID NOT ITCH.
Information has been received from a 27 year old female consumer with no medical history or allergies who on 13-AUG-2009 was vaccinated IM, 0.5 ml, with the first dose of GARDASIL injection (lot # 661841/0653X), the second dose of GARDASIL injection (lot # 661841/0653X) on 29-OCT-2009, and the third dose of GARDASIL injection (lot # 661841/0653X) given in left deltoid on 25-FEB-2010. Concomitant therapy included ESTROSTEP. On 26-FEB-2010 the consumer had pain in her arms when typing and felt swelling under her left arm. There were no laboratory studies performed. The consumer called the doctor on 01-MAR-2010 to report this. The area was still swollen but getting better and the consumer did not want to be seen by the doctor. The consumer had no adverse symptoms after the first and second dose of GARDASIL. Follow-up information has been received from a certified medical assistance concerning the 27 year old female manager with no medical history or allergies or illness at time of vaccination who on 25-FEB-2010 at 09:45 was vaccinated IM with the third dose of GARDASIL (lot # 661841/0653X) in her left deltoid. The patient called the office 4 days after receiving vaccine complaining of swelling and pain under arm that started the day after the vaccine on 26-FEB-2010, but that was already much better. There were no laboratory studies that were known to this office. The patient declined visiting doctor of medicine (MD). On 05-MAR-2010, the patient "felt great" and recovered. Additional information is not expected.
body aches; headache; low fever; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 42-year-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 16:45 pm (age at vaccination was 42 years) as UNKNOWN, SINGLE dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. On 12Feb2021, the patient experienced body aches, headache and low fever. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored (Wistar RA 27-3) M-M-R II with lot number M010426 and expiration date of 01-MAR-2018 (strength, route of administration and dose were unknown), which was stored at 35 Fahrenheit degrees for 1 hour and 47.5 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
five blood blisters in mouth (two large blisters under tongue, one large blister on inside lower lip, two small blisters on inside left cheek)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: High blood pressure; "Blood cholesterol" (unspecified if ongoing), notes: high cholesterol. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment".anti viral details :product: COVID 19 Treatment. brand: Paxlovid, treatment start date:01Jul2022, treatment stop date:06Jul2022,indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
07/11/2006 MILD Other LOCAL RED ELEVATION WARMTH WITH WHITE RING AROUND
itching and small red marks     then red spot under vaccine administretion point. {size of  rednes about the size of palm of hand]  hand] Still  red and warm
Pt developed lightheadedness within 5 min of vaccine , HR 98, Pulse Ox 99%, T 97.3, B/P 150/98 right arm. 10 min past injection pt developed sensation of lip swelling and SOB Benadryl 25mg given PO. Pt transferred to  ER. Of note pt did have similar reaction with hives and swelling at injection site that developed 7 days past injection with Primary Provider ordering a course of Dexamethasone that lasted for  8 days total.
pt recv vax 31AUG95 & 3SEP95 pt began to exp leg & joint pain, & diarrhea;presented to vascular surgeons, orthopedic specialists & eval;1yr p/vax pt upper thighs & buttock are very sensitive;pt felt debilitated;
Headache for the past 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for the past 5 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEADACHE (Headache for the past 5 days). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache for the past 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Swelling at injection site occurred evening of 1/27, tingling in lips.  Took 2 benadryl 1/28 and 1 benadryl this am 1/29.  Has reduced swelling around injection site, but still red.  Reporting this way since I did not have any issues when receiving the texts through v-safe and will not receive another text now for a week.
Abdominal pain; diarrhea; body aches; lethargic; chills; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9263), dose 1 via an unspecified route of administration, administered in arm left on 20Jan2021 at 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient had known sulfa and penicillin allergies and other medical history hypertension (HTN) from an unknown date and unknown if ongoing. Patient was received other medications (unknown) in two weeks. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced abdominal pain, diarrhea, body aches, lethargic and chills on 09Feb2021 at 19:00. It was reported that it was unknown if the patient received any treatment for the events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
~12 hours post injection I woke up sweaty in bed with chills (05:00 1/26/22); Awoke around 11:00AM 1/26/21 with a fever of 103.2F, verified twice by two thermometers. Other symptoms included a very sore arm, and extensive body aches.  At 20:00 1/26/21, fever remained at 102.8F, still body aches. I awoke at 0800 the following day 1/27/21 to a fever of 101.4F, body aches maintained. Fever maintained a range of 101.4-100.1 for the remainder of the day, body aches lessened, but still present. Awoke 1/28/21 feeling well. No fever no aches.
RECEIVED PHONE CALL FROM MOM, ON 8/23/2007 THAT CHILD COULD NOT WALK ON LEGS TODAY.  MOM WANTED TO KNOW IF THESE COULD BE FROM VACCINES.
Side effects; Stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) and GASTROENTERITIS VIRAL (Stomach flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects) and GASTROENTERITIS VIRAL (Stomach flu). At the time of the report, VACCINATION COMPLICATION (Side effects) and GASTROENTERITIS VIRAL (Stomach flu) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported.  No treatment information was reported by reporter.   Reporter did not allow further contact
Approx 9 days after receiving his one year vaccines the patient developed a rash all over his body. Worse on chest and back but noted on extremities and a couple on his face. Pink or red spots. It was smooth and not raised. He was cranky but ate and drank ok. He also developed a fever 102.6 at the highest.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIVALO. Past drug history included: Sodium lauryl sulfate for allergic to sodium lauryl sulfate, notes: allergic to sodium lauryl sulfate. Vaccination history included: Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose number unknown, Booster dose), for Covid-19 immunization; Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose 2), for Covid-19 immunization; Bnt162b2 (Caller states all of her Covid-19 Vaccines and boosters have been Pfizer, Dose 1), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: She stated all of her COVID-19 Vaccines and boosters had been Pfizer. She stated that she had no reactions to any of them, except a sore arm for about an hour. She stated that she kept an ice pack in her freezer for after shots so that she can put it on for an hour or two. She stated that she had no fever or any other side effects.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Vaccine given on 11/28/07.  Child broke out with chickenpox on 12/2/07.  95-100 lesions.  Slight fever.  Resulted in trip to hospital.  Culture of lesion cat scan to CDC on 12/7/07.