chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients received a Flu shot from an extended shipment of Fluzone Quadrivalent, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA278134, 2019SA278135, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140 and 2019SA271944 (same reporter).  This case involves a patient who received a dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] (lot: UJ254AC, expiry date: 30-Jun-2020) via unknown route in unknown administration site, on an unknown date, from an extended shipment and they were not suitable for use.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  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.
Ee stated she started to feel dizzy. V/S as followed B/P: 96/60 P: 63 O2: 99. Ee stated she was feeling clammy and she usually gets this way when given vaccines. Adverse reaction started appro 7:38 pm. Ee felt better approx. 7:46.
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 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Jan2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing), notes: Verbatim: Stroke; "Seizures", start date: 2014 (unspecified if ongoing), notes: Verbatim: Seizures. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 immunization, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: INJECTION SITE INFLAMMATION (non-serious) with onset 30Jan2021, outcome "unknown", described as "bump appearing on the injection site"; INFECTION (non-serious) with onset 30Jan2021, outcome "unknown", described as ""something black" came out and has a little odor to it."; SKIN ODOR ABNORMAL (non-serious) with onset 30Jan2021, outcome "unknown", described as "a little odor". Additional Information: This is Non Serious case. Reporter stated that he noticed a bump appearing on the injection site of his left arm a few days after he received his booster dose and this has happened at two different times. He said that the when he rubbed the bump, "something black" came out and has a little odor to it. A few days later when the caller was cleaning a little more came out of it, no more has come out since then. He also said that he was fine from his first two doses but for his booster dose, this particular bump with a black excretion and little odor appeared. The caller had just gone to his primary care provider before he took the booster shot. This bump wasn't on the caller's arm after the first two shots, it showed up after the third shot. It happened two times and hasn't come no more. When the caller wiped himself with a towel the paste came out and had a little odor. The caller smelled it and it had a light odor to it. The caller was in a panic because he had to take his medicine to his doctor and they said there shouldn't be any problems with them interfering with the vaccine. The caller took his medicine to his neurologist and they said there shouldn't be any conflict with the medicine and the shot. Then the caller took his shots. Reason for no lot number of Pfizer Covid vaccine was mentioned as, The caller does not have his vaccination card with him. Patient taking Pfizer Covid vaccine (Verbatim) because, every one was telling him to take. Additional Information for Other Conditions: The last one was in 2014. The lot number for [BNT162B2], was not provided and will be requested during follow up.
Started w/ 102.3 temp the evening of vaccine admin. Other symptoms/SEs included nausea, headache, and dizziness. Not as well the next morning but fever broke and symptoms seemed to subside within next 24hrs.
This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. The patient's historical drugs included PREVNAR. Medical history was not reported. Concurrent conditions included cancer. On 23-APR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date and route of administration was not provided) at a dose of 1 injection given to an unknown arm for immunisation. Concomitant medications included unspecified cancer treatment. On 23-APR-2018 sometime after the patient was vaccinated, she could not move the vaccinated arm (vaccination site movement impairment). The patient took unspecified doses of TYLENOL to relieve the symptoms. The patient visited physician to seek medical attention. The outcome of vaccination site movement impairment was unknown. Causality assessment was not provided by the reporter.
This is a spontaneous report from a contactable physician. A 78-year-old female patient of an unspecified ethnicity started to receive LIPITOR, epinephrine (unspecified manufacturer), codeine (unspecified manufacturer), sulfa, ZOCOR, and ZETIA; all via an unspecified route of administration from an unspecified date, at an unspecified dose and frequency, for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was allergic to atorvastatin calcium, codeine, sulfa, epinephrine, simvastatin, ezetimibe on an unspecified date. Upon follow-up on 11Dec2012, the physician further reported that the patient is reported to have various reactions ranging from fatigue to myalgias to abdominal pain to nausea from the others listed, none of which were serious. The action taken in response to the events for atorvastatin calcium, epinephrine, codeine, sulfa, simvastatin and ezetimibe was unknown. As of 11Dec2012, the outcome of the events was unknown. On 26Feb2013, the physician reported that the patient was also allergic to NORVASC, lisinopril, PREVNAR, COZAAR, VICODIN and HIDROLASE. Pfizer is the Marketing Authorization Holder of epinephrine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of epinephrine has submitted the same report to the regulatory authorities. Follow-up (11Dec2012): Follow-up attempts completed. No further information expected. Follow-up (11Dec2012): New information reported from the same contactable physician included: reaction data (added events "fatigue", "myalgia", "abdominal pain", "nausea" with seriousness assessment). Follow-up (07-FEB-2013): Follow-up attempts completed. No further information expected. Follow-up (26Feb2013): New information received from a contactable physician stated that: patient was also allergic to NORVASC, lisinopril, PREVNAR, enalapril, COZAAR, VICODIN and HIDROLASE. Follow-up attempts completed. No further information expected.
Information has been received from a 59 year old female patient concerning herself. Information regarding medical history and concurrent condition was not provided. The patient had no drug allergies/reactions. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength and lot# were not reported) in the left arm. Concomitant therapies were not reported. On unspecified date in December 2014 (reported as "3 months ago"), the patient noticed that she had a hard lump, bruising, itching and bright red spot which liked as if a baseball had hit it that lasted for several weeks. At the time of reporting, the hard lump had lasted for 3 months and the outcome of bruising and itching were unknown. The reporter wanted to know how long the hard lump would last. No lab diagnostics were performed. The patient had not sought medical attention. The causality between the adverse events and ZOSTAVAX was not reported. Additional information is not expected as the physician's information was not provided and the physician didn't want to be contacted.
Child exhibited uncontrollable crying for approximately 6 hours accompanied by a fever varying from 102 to 103. Fussy for approximately 24 hours.
Rash heavily concentrated on chest, neck and upper back. Few red spots on lower limbs but not concentrated or as inflamed.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about patient 04 out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Whole body ache  fever  can?t lift my right arm  right arm pain Nauseated   headache in my right temple  pain in my side and back on the right upper  my teeth hurt Tired Sore Extremely thirsty  Jaw pain
having trouble walking; legs hurt/hands hurt/Her legs and her hands worsen every week, every month; crying; She can't write now anyway; They go to sleep all the time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EP7533, Anatomical location: right arm), administration date: 29Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: EP7533, Anatomical location: left arm), administration date: 19Apr2021, for Covid-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "having trouble walking"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurt/hands hurt/Her legs and her hands worsen every week, every month"; CRYING (non-serious), outcome "unknown"; DYSGRAPHIA (non-serious), outcome "unknown", described as "She can't write now anyway"; HYPERSOMNIA (non-serious), outcome "unknown", described as "They go to sleep all the time".  Additional information: She said that she took the COVID Pfizer vaccine booster, and since she received it her health became worse. She was having trouble walking and getting out of bed, including sitting up. She was crying. Her legs hurt all the time. She cannot write any-way. Her hands hurt too bad. They go to sleep all the time. This is all since the vaccine. Before the vaccine she was able to paint her walls with a brush. Now she cannot even paint a fingernail now. After the booster, she started to experience it within 30 days. Her problems were bilateral, and more in her legs than her arms. She has had no other vaccines. Prior Vaccinations within 4 weeks were none.  No follow-up attempts are possible. No further information is expected.
Chills 102 fever Achy Headache  12 hours  Took 800 mg ibuprofen and zinc and vitamin d
Fatigue, joint pain, muscle pain, nausea, headache, loss of appetite, chills, injection site pain
7 days post vaccine administration pt developed lumps/rash at injection site. Upon waking up the following day pt reports having trouble swallowing, shoulder was swollen, itchy and redness at the site.  Accompanied by agitation and itchiness.
10 minutes after the last vaccination (sequence- DTaP-MMR-IPV). Pt fell and went into a tonic spasm with arching of the back and brief loss of consciousness, no frothing at mouth, no incontinence of urine or stool. Episode lasted about 5 seconds. Pt recovered completely and started talking and walking normally. No past history of seizures. Temp 97.8.
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received 0.25 mL dose of vaccine FLUZONE QUADRIVALENT lot UT6259LA, expiry date 30 June 2019 via unknown route in unknown administration site on 18-Dec-2018. The patient's past vaccination(s) included FLUZONE QUADRIVALENT with 0.5ml, Intramuscularly in left thigh left thigh. No other medications or vaccinations were given either time. It was a case of actual medication error due to vaccine underdose. It was reported that the patient was given the correct dose (.5ml, IM, left thigh). One month later the patient was given incorrect dose of .25 ml. Patient received the correct dose the first time and the incorrect dose the second time. 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.
pt recv vax 6AUG97 & AUG97 pt exp ear infect & was placed on ATB therapy;approx 22AUG97 pt exp a fever;on 24AUG9y pt exp rash w/blisters & about 20 vesicles;
After a week from the date he received the 1st dose, he tested positive; runny nose; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 68-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown, expiration date: unknown) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Mar2021, patient experienced after a week from the date he received the 1st dose, he tested positive and runny nose on an unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-COV-2 TEST: negative on by that Monday we were both reported as negative, he and his girlfriend, SARS-COV-2 TEST: positive on 04Mar2021 he had a swab test on this past Tuesday and it was confirmed positive as of yesterday, 04Mar2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
muscle ache; Headache; Chills; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MYALGIA (muscle ache), the second episode of HEADACHE (Headache), CHILLS (Chills) and the first episode of HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and the first episode of HEADACHE (Headache). On 04-Mar-2021, the patient experienced the second episode of HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL) on 27-Feb-2021 for Headache, at a dose of 1 dosage form. On 01-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN (Body aches), MYALGIA (muscle ache) and the last episode of HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported
pt recv vax; one day post vax pt exp a 4 cm area on his arm @ inject site which was red, hot, tender, and swollen. pt complained of sleepiness
Left axilla pain, painful area posterior left axilla, swollen firm lymph nodes to left lateral axilla/ breast, tenderness soreness to left brachial inner elbow up  left bicep into axilla
Information has been received from a registered nurse concerning a female patient who was vaccinated with PNEUMOVAX 23 subcutaneously. Subsequently the patient developed a severe localized injection site reactions while in the hospital for other health issues. The patient was not hospitalized because of injection site reaction, but rather, the reaction occurred while in the hospital for another issues. The patient had sought medical attention. At the time of report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient felt no pain the day of vaccination. The next day, in the morning, she felt dizzy and a lot of pain across her chest. She tried to get up from bed and collapsed, hit her head, and ended up with a compound fracture.
circular red area noted to rt deltoid approx warm to touch;DTAP given 28APR(7;to apply cold compress RTC 6wk or sooner PRN if needed;
Left leg swollen to below the knee, very warm, mild erythema. Pt treated with Keflex for early cellulitis.
Patient received 4th dose of pediarix at 15 month appointment. Patient had no adverse reactions.
chicken pox by physician clinical diagnosis 1 week after vaccine; 6 month old brother contracted same approximately 1&1/2 weeks after brother (no other known exposure)
12 x 14 area of erythema and swelling Rt ant/lat thigh
Twenty four hours after the shot was administered pt experienced severe swelling at the neck especially his left lymph node. He was hospitalized for strep-pneumonia in July of 2000 and wondered if there was a connection. I wanted to communicate this info so it could be tracked and help other children and physicians. Noticed when he woke up from his nap. I was told he had a bacteria.
Rash on both arms and legs; A spontaneous report was received from a Consumer concerning a 83 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event: rash.  The patient's medical history includes Stroke. Relevant concomitant medications reported include Lipitor, amlodipine and some she can't remember.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient received the Moderna vaccine on Saturday, 16-Jan 2021 on left arm. Woke up the next day with both arms with rashes as well as legs. She took a Benadryl for the treatment of rashes. The rashes have not gotten worse but are still there. She is taking lipitor, amlodipine and she can't remember. Medical history includes stroke.    Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event, rash on both arms and legs were unknown.
Syncope, pale and cool skin. B/P 113/76, and 114/75, P-68, P-78, R-18, R- 18. Pulsesats- 99%. Given breakfast and snacks. No previous reaction to vaccine.
Patient came in to get information about scheduling her covid vaccine on 4/111/22 and she filled out the VAR form given to her.  When she turned in the VAR she stated she did not want vaccine today but would come back the next day.  Patient returned to pharmacy and I gave the VAR she filled out the day before to the technician to enter her vaccine for her second dose of covid 19 vaccine.  She did not have card but had image on her phone. I did not look at phone since I looked her vaccination record. I viewed the date of her last vaccine and deemed it was   ok to give her second dose base on the date of her first vaccine. I did not view which vaccine she received. I reviewed the VAR and prepared the 0.5 ml Moderna vaccine and proceeded to give patient the immunization.  After the vaccination the patient returned to the counter and said she wanted Pfizer.  I told the patient that the CDC approved mixing and matching vaccines..  Upon further investigation that is only the case in certain circumstances for the primary series and for boosters.
spots that come and go; itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching). At the time of the report, INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated Reporter Information
Patient stated that she has never had an issue with any flushot in the past, but this vaccine affected her within minutes of being administered.  She stated she had no injection site reaction, but very shortly after receiving the vaccine felt really dizzy and weird.  She stated she had to sit down for about 10 additional minutes.  She stated the next morning, she could barely stand to raise her arm due to the pain in her deltoid area that was radiating down to her last two fingers in her hand causing some numbness and tingling.  She stated it made her feel like her bones in her arm were aching as well.   She stated that she is still having these issues a full month later.