chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt very hyped up after the vaccine; couldn't sleep at all last night; Iam very different; This is a spontaneous report received from a contactable consumer (patient). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Patient medical history included Thyroid condition. Concomitant medications were not reported. Patient stated that "she felt very hyped up after the vaccine. She went to work and she felt very different from what everyone was saying. She couldn't sleep at all last night". Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse refers to a 22 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter stated that "the patient blood work showed that she needed a booster shot of RECOMBIVAX HB 2.5/0.5 (date of test unspecified). The reporter could not specify which hepatitis B vaccine was previously administered to the patient. On an unknown date the patient was inadvertently  vaccinated with pediatric dose of RECOMBIVAX HB 2.5/0.5  lot # L016959 expiry date 12-MAR-2018 (drug administered to patient of inappropriate age) for prophylaxis and no adverse effects were reported. Unspecified treatmetnt was given to the patient.
went for a walk and felt really tired; blood pressure goes from high to low; blood pressure goes from high to low; Nocturia; A spontaneous report was received from a consumer concerning a 92 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced going for a walk and feeling really tired, blood pressure going from high to low and waking up to go to the bathroom three times.  The patient's medical history was not provided. Concomitant product use was not provided.  On 11 Jan 2021, the patient received their dose of mRNA-1273 (Lot number 012120A) in his left arm for prophylaxis of COVID-19 infection.   The patient stated that the same day of the vaccination he went for a walk and felt really tired, which was something uncommon for him.  The next day he woke up and took his blood pressure and it was high.  After breakfast he took the pressure again and it was low.  He also mentioned that overnight he had to wake up three times to go to the bathroom.  There were no treatments for these events.    The events, going for a walk and feeling really tired, blood pressure going from high to low and waking up to go to the bathroom three times were still recovering as of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (each time she got the Moderna Covid-19 vaccine she got wipe out the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergy to Clindamycin). Concomitant products included AMLODIPINE BESYLATE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day). At the time of the report, FATIGUE (each time she got the Moderna covid19 vaccine she got wipe out the next day) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2022-525752, MOD-2022-525757 (Patient Link).
administered post the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered post the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    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 EXPIRED PRODUCT ADMINISTERED (administered post the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered post the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  It was reported that some patient received Moderna vaccine on 10-NOV-2021, 11-NOV-2021 and 12-NOV-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received vaccine expiry date was added.
This spontaneous report as received from a healthcare worker refers to a patent of unspecified age and gender. No current or historical conditions were reported. On 23-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unkown. This is one of several reports received from the same reporter. Additional information is not expected because the reproter had no further information available.
Arrived at school with severe involuntary movements, almost like Tourettes gone berserk. All limbs and head involved. Scratched and bruised b/c fell on way to schhol bus. Grandma took to ER
Initial report was received on 24 February 2012 from a health care professional. An 11-year-old male patient, with no concurrent illness, had received an intramuscular injection of ADACEL, lot number C1008AA and MENACTRA, lot number U4074BA on 20 February 2012 (sites of administration not reported). The patient had a history of a peanut allergy, asthma and capillary hemangioma that was present on the left deltoid since birth. According to the reporter, the capillary hemangioma "went down" over time. On 23 February 2012, three days post vaccination, the patient's parents called the office to report that the hemangioma developed again, describing it as bulbous, raised and red on the left deltoid where vaccine was administered: the vaccine administered at this site was not specified). Laboratory or diagnostic testing was not performed, and the event did not require a doctor's visit. It was unknown if the patient had experienced and adverse events following prior vaccinations. Outcome was not recovered. Documents held by sender: None. The follow-up information was received on 07 May 2012: The patient mother stated that the prior to immunization Hemangioma was faint ashen in color and flat followed the immunization area become bulbous, dark red, purple which laste for one week. Hemangioma had returned to pre immunization state in color and size.
SICK AFTER THE VACCINATION; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 sick after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick after the vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20221003166.
This report was received from a health professional on 14 November 2007. A 19-year-old female patient, with a history of diabetes, received an intramuscular left deltoid injection of FLUZONE (lot number U2441AA) on 17 October 2007. That evening, she developed red blotches at the injection site. She also became sleepy and subsequently slept for 10 hours, which the reporter stated was abnormal for her. The following day, the patient complained of nausea and fatigue. The nausea resolved on 18 October 2007, and the fatigue continued for an additional 24 hours.
expired dose was administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 20th March 2022) for prophylaxis.   On 16th May 2022, the patient received Menveo. On 16th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The physician reported that a dose of Menveo was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Menveo dose which was already expired on 20th March 2022, which led to expired vaccine used.
Red itchy rash (hives) covering her legs to her feet, torso, and arms down to her hands and especially near where shot was given.  Took her to doctor and gave her anti-histamine. It cleared up in a week. Pt also had headache.
patient's that received the diluent DTaP/IPV of the Pentacel, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA268503 (same reporter).  This case involves a 4 months old female patient who received 0.5 ml dose of diluent DTaP/IPV of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ101AAA and expiry date: 19Sep2020) via intramuscular route in the right thigh. This patient received the diluent of the DTaP/IPV which was the second dose of a DTaP and a IPV for this patient  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); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no adverse 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 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 sender: none.
Raised welts and hives on both knees, both elbows, shin and thigh.
pt recv vax & pt presented to MD office w/two different rashes;one was a papular rash w/an erythematous border which was predominately above the nipple line w/lesions on nose, neck, ear & back;2nd rash fine macular rash
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 07Feb2021 as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. Patient got the vaccine, the first one, she got the shot on Sunday night and had the chills and the join ache, just little time and thing like that. Now in the last about a day she feel like she loosing a little bit of taste and smell. 07Feb and about a day later she started experiencing the joint pain and she does not feel great in general. That's how she described it feeling unwell, but she said it's not enough that she cannot deal with that. On Feb2021 the patient experienced joint pain, joint ache, i don't feel great/i don't feel real good/does not feel great in general, i had the chills, i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different. Therapeutic measures were taken as a result of joint pain ,joint ache , i don't feel great/i don't feel real good/does not feel great in general , i had the chills , i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different, i started to lose a little bit of my taste and smell/i am loosing a little bit of taste and smell/started to lose a little bit of her taste and smell; taste is different,. Treatment included Last night she took some Ibuprofen. The outcome of events was not recovered.
Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine (+) HIB conjugate vaccine that was administered on 6/1/98 (lot # 624776/0166H), 7/31/98 (626889/0738H), and 4/5/99 (lot # 630228/1918H). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC).
Right arm erythema, pain and swelling distal to pneumococcal 23 vaccine injection site. Fever to 103 over weekend with emesis/diarrhea per telephone call to provider. Pt admitted for IV antibiotics.
pt recv vax 20SEP95 & 14MAY97 pt devel chickenpox that consisted of greater than 50 lesions on back, trunk, face, arms, & abd;
This spontaneous report was received from a nurse practitioner via a company representative, concerning a 16 year old female patient. Medical history and concurrent conditions were not reported. On 28-MAY-2014, the patient was vaccinated with the first dose of GARDASIL (strength, lot number and expiration date were not reported), intramuscular route, 0.5 ml. Co-suspect and concomitant therapies were not reported. On 29-MAY-2014, the patient experienced pre-syncope, consisting of lightheadedness, which remains unresolved. At the time of the report the outcome was not recovered. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, contusion and fatigue. On an unknown date, the outcome of the pain in arm, contusion and fatigue were unknown. It was unknown if the reporter considered the pain in arm, contusion and fatigue to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient described his experience with his first dose of SHINGRIX in early 2018. The patient reported having pain in his arm that prevented him from golfing for 1 to 2 days, bruising and fatigue. The reporter did not agree to follow up.
Hotness on arm, red blotch patch odd shape, arm stiffness from elbow up to back of neck to the right side of neck. Light dizziness, chills, sleepiness. Called my pharmacy they never called back, took tylenol didn't really help so I called my Dr.  and she proscribed me a Medrol pak to take. The pain lasted 3 days the first time the odd red patch stayed for a week. The second shot I got June 18th at 4 pm, the odd patch shape lasted from the shot day till June 25th.  Still have warmness in the arm and hurts on and off.
Very swollen and painful left arm started the night of vaccine. Observation only. Had to come back into doctor's office to evaluate.
onset of fever 26APR99 up to 104;fever cont until day of 28APR99;on april 28th few rash spots;afeb @ time of rash onset;more rash in April, then generalized rash on 30APR;pt cranky but not ill;
Nocturnal seizure on the morning of February 2, 2021. First seizure/epileptic event of lifetime.
10am - vaccine administration 10:30am - went to sleep 4:00pm - woke with numbness and difficulty moving right side of face ability to move right side of face decreased for the next 48 hours until unable to eat, drink, breath, or blink normally. symptoms still present as of 04/23/2021 with no improvement
Information has been received from a consumer concerning her 16 year old daughter with penicillin allergy who in September 2008 and February 2009 was vaccinated with the first and second doses of GARDASIL (route and lot# not reported). In February 2009, the patient experienced mononucleosis. The patient had not received the third dose of GARDASIL due to being diagnosed with mononucleosis. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
pt recv vax JUL96 & 19JUL96 pt exp swelling of the parotid glands;pt recovered;
Within a few minutes of receiving the shot I experienced mild dizziness that lasted only a few minutes.  Then, starting within a few hours after the vaccine I experienced symptoms of headache, fatigue, body aches, decreased appetite that lasted  for about 36-48 hours after the vaccine administration and then resolved.  I am also a breastfeeding mother and my breastfed infant also experienced symptoms of elevated temperature, fussiness/inconsolable crying, decreased appetite, mottled skin, and diarrhea all occurring within the 48 hour window after I received the vaccine.
Redness and rash at injection site.  Quickly resolved.  Patient reported no prior Pneumovax at time of injection.  However, after rash formed, she then recalled that she had taken the Pneumovax IM in January of this year at a local pharmacy along with her flu shot.  This is the reason for the report.
17 year old received first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-254000 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant information Appended. 2nd dose details provided .
2 Miscarriage's directly following vaccine. Had two pregnancies beforehand with no complications to the baby or mother. Mother in perfect healthy condition.
she was "12 weeks pregnant". The Patient had agreed to the vaccination prior to receiving the GARDASIL 9; Information has been received from a physician referring to a currently 24 years old female patient. Concomitant therapies included cetirizine hydrochloride (ZYRTEC) and iron (unspecified), minerals (unspecified), vitamins (unspecified) (reported as prenatal vitamins). The patient had sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA) allergy, and egg white/shrimp allergy which caused stomach upset. The patient also had allergies (not specified), wisdom teeth extraction and appendectomy.   The reporter reported that the patient was seen on 08-JUL-2019 for a corporate physical/vaccination prior to going overseas with spouse for work. The patient was given hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot N013698, expiration 19-DEC-2019, intramuscular, in right arm; strength and dose were not reported) for prophylaxis prior to seeing the physician (Exposure during pregnancy). The patient remarked that she was "12 weeks pregnant". Date of LMP was 15-APR-2019. Due date was 20-JAN-2020. Pregnancy outcome was outcome pending. Gestation period at exposure was 12 weeks. The patient had agreed to the vaccination prior to receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was also scheduled to see her obstetrician after this visit on 08-JUL-2019. Treatment was given. No lab test was performed.
Day 10 after vaccine administered, developed 2 pox like lesions (non-weeping) at the injection site.  Injection site then swelled to about 1.5in in diameter, round and smooth. Gave ibuprofen and swelling went down. Day 11, area is still swollen but now in an uneven, bumpy pattern, and pox are now visible at the area again. Area is painful, but child does not have a fever.