chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Medical assistant stated that the wrong vaccine was pulled from the refrigerator and there was no double check done prior to administration.; This spontaneous report was received from Other Health Professional and refers to a 6-month-old female. The patient's pertinent medical history and concomitant therapies were not reported.  On 08-NOV-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot # w029533, expiration date: 07-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided).  On 08-NOV-2023, the medical assistant stated that the wrong vaccine (Wrong vaccine administered) was pulled from the refrigerator and there was no double check done prior to administration.
Pt called 12/16/10 approximately 0900 to report bad reaction to vaccine. Reports the left arm sore as of 2:00p 12/15 - hurts to move it. Fever of 101 degrees at 7:30p 12/15 - took 12/16 off work as hurts "all over". Denies any hardness, redness or soreness at (L) arm site however. Treated w/XS BAYER aspirin & rec f/u 12/17 of not improving.
Dry scaly itchy plaques near the elbows (right and left) and a few on the right forearm. No Hives, no joint swelling, no other symptoms. It looked very similar to a mild case of psoriasis. I have never had anything like this in the past. It resolved after a week.
This spontaneous report as received from a consumer (also reported as mother of the patient) refers to a 14 year old female patient. The patient's pertinent medical history included eczema. It was reported that the patient did not have any drug reactions/ allergies and was not taking any medications concomitantly. On an unknown date in July 2017 the patient was vaccinated with first dose in series of GARDASIL 9 (lot number and expiry date unknown) 1 injection in the left arm (route unknown) to avoid Human papillomavirus (HPV). On an unknown date approximately in July 2017 (also reported as a few hours after vaccination) the patient's left arm became slightly swollen, very red, painful and warm to touch. It was reported that the patient did not seek medical attention. Lab diagnostics studies were not performed. It was reported that the arm was treated with cold compress and the patient recovered in 2 days. The outcome of the events was reported as recovered. The relatedness of the event to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported.
injection site hot; red (rash)/ red (rash); super hot; rash/ rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)), FEELING HOT (super hot) and RASH (rash/ rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (rash/ rash). On 25-Mar-2021, the patient experienced INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)) and FEELING HOT (super hot). On 24-Mar-2021, RASH (rash/ rash) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site hot), RASH ERYTHEMATOUS (red (rash)/ red (rash)) and FEELING HOT (super hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Developed nausea 10/3/09 and vomited with diarrhea x 4 times on 10/3/09. T-99.1. Chills, backache. Improved 10/4/09 but cont with nausea throughout 10/4/09 and AM 10/5/09.
Two male patients received VARIVAX intramuscularly instead of subcutaneously; No additional AE were reported; This spontaneous report was received from a pharmacist, and refers to a male patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneously for prophylaxis (dose, lot number and expiration date were not reported). No adverse events were reported.  This is one of two cases received from the same source.   ; Sender's Comments:  US-009507513-2110USA003312:
Nausea, fever, body aches, shortness of breath, cough, diarrhea
After nine days, a red rash in a circular form what is evident around the injection site. The area of the skin seems either swollen or hard and is tender to the touch, as if it were a bruise or punch in the arm.
This spontaneous report was received from a patient's mother and refers to a 16-year-old female patient. The patient's medical history included a lot of Staphylococcal infections on skin, 3 in the past year. Her concomitant medications included unspecified dermatology medications for skin. The patient had no drug reactions or allergies. On 15-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (dose, lot number and expiration date were not reported), for prevention from Human papillomavirus (HPV). On 24-MAY-2017, the patient experienced a six minute seizure where she was totally unconscious. She fell to the floor and cracked her jaw, but no teeth were broken. She lost control of her bladder. The patient was taken to an unspecified emergency room (ER) by her father. On the way to the ER, the father noticed blotches on her arm, but by the time they got to the ER, the blotches had already resolved and were not seen by the ER personnel. At the ER, the patient received oxygen; no other treatment was given. The patient was not admitted into the hospital. The patient had a Computed Tomography (CT) scan and a Magnetic Resonance Imaging (MRI) on her head performed on an unspecified date in May 2017, after the ER visit. She also had an Electroencephalography (EEG) performed on 31-MAY-2017. The results of CT an MRI were reported as "negative", but the EEG was "positive". The patient would see an unspecified specialist on 01-JUN-2017 (reported as "later today"). The reporter thought that the patient would be prescribed an unspecified anti-seizure medication. The outcome of the seizure and being totally unconscious was resolved after 6 minutes on approximately 24-MAY-2017. The outcome of blotches on her arm was resolved on an unknown date in May 2017. The outcome of the cracked jaw was reported as improving and the outcome of losing control of the bladder was not reported. The patient's present status was reported as "not feeling good". The causality assessment between the events and GARDASIL 9 was not provided. Upon internal review, the events of seizure and being totally unconscious were considered to be medically significant. Additional information has been requested.
Redness, warmth pain swelling of entire arm large oozing blister numbness around shoulder and neck
Patient reported to pharmacy with a red arm, described swelling, heat, and tenderness from previous days, but that it seemed to be resolving on its own.
Pt received Zostavax 0.65 ml subcutaneously in left arm on March 5, 2008.  Approximately 3 days later she reported mild erythema to shoulder of arm where she received vaccine.   Pt. and Dr. had discussed treatment for possible cellulitis earlier and so non March 8, 2008 pt began emperic treatment of cellulitis with Doxycycline 100 mg.  Pt. reported great improvement after two days of antibiotic, (March 10, 2008)
Says body got itchy & burned for about 2-3 min. Husband spoke with a physician that told her she should report a reaction to shot. He said she was "allergic to eggs." Encouraged to call her physician.
Severe Arm Pain, felt nausea immediately after... went home and was up all night with severe arm pain and my heart was racing and i could not sleep- the worst was the muscle spasms in my upper leg? felt like a horrible charley horse- it happen a few times the next 2-3 days..  it has not happened lately but i have had nasal congestion since getting the second shot that hasn't gone away?
Pt felt dizzy after her injection. Rested, ate a snack then felt better. Vital signs remained stable
a bad cold; still got the Delta virant and a bad cold; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media .  This case involves Adult male patient who experienced a bad cold and still got the Delta Virant and a bad cold (covid-19 and nasopharyngitis), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a Delta virant and a bad cold (covid-19 and nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported I actually got both covid shots and a flu shot I actually wear 3 masks and two condoms and I still got the Delta virant and a bad cold and still got my girlfriend pregnant.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
headache; This is a spontaneous report from a contactable consumer (patient's Sister). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration, on 01Mar2021 as a single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient experienced headache. On 03Mar2021, the outcome of the event was reported as recovered.  No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected
Patient had nausea and vomiting starting in the evening on 3/12/21.  Patient was able to sleep that night.  She woke up the morning of 3/13/21 and  had repeated episodes of nausea and vomiting.  EMS was called to her house.  Her vitals were stable so EMS left.  Around 1 pm on 3/13/21, her husband called our pharmacy and made us aware of the situation and asked for advice as she is unable to keep fluids down.  Advised that she should be taken to hospital for care.
high blood pressure averaging 170/100 constantly daily with chest pain, prior to vaccine average 130/76.  Placed on Losartan 25 mg, 2t Qam and 1 t pm - not working
No additional adverse effect; a patient received improperly stored PROQUAD; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 21-JUL-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided; lot number S027466 has verified to be valid, expiration date was reported and validated as 02-MAR-2021) as prophylaxis (product storage error). It was reported that the sterile diluent used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).   The administered vaccines were stored in a temperature of 47 degrees Fahrenheit (F) to 77 degrees F (66 degrees F) for 3 days, as recorded by a data logger. There was no previous temperature excursion reported. No adverse effect was reported.
Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
sore throat; slightly tender lymph nodes; redness; slight exudate; This is a spontaneous report from a contactable physician (patient) through the Pfizer-sponsored program. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient developed a sore throat and had slightly tender lymph nodes in his right anterior neck with redness on the side and slight exudate, with no other symptoms. He got tested for COVID-19 to be sure he did not have it because he did not think this was the case. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I experience sore arm (injection arm); redness near the injection site; tired; minor chills; body ache; joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Mar2021, patient experienced I experience sore arm (injection arm), redness near the injection site, tired, minor chills, body ache, joint pain. Patient reported that I experienced more severe adverse event for about a day started the day after injection. I became really tired on Tuesday afternoon, and started to have minor chills, body ache and joint pain. There was no fever. All the adverse event except a little arm pain have resolved on Wednesday. The clinical outcome of event vaccination site pain was not recovered, and other events was recovered on 03Mar2021.  No follow-up possible are possible, Information about lot/batch number cannot be obtained.
Low grade fever throughout day around 101. Went up to 103 overnight on 2nd night.
My second  COVID Pfizer Vaccine was April 27th,   For the first time since my period started 35 years ago, my period came 5 days early on May 4th instead of the expected day of May 9th.  t was different than how my usual period starts. It was brownish in color and a very heavy start that has not happened in the past.
Information was received from a healthcare professional referring to an adult patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unspecified date in January 2018, the patient  was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On 15-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (lot number R008165 and expiration date of 12-NOV-2020; however, dosage schedule, route of administration and anatomical location were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
Severe swelling and raised skin at injection site (>3" diameter), painful to touch or move arm - resolved at approximately 8 weeks.  flu like symptoms of fever and aches - resolved after 3 days.
Dental work with injectable anesthesia/right upper teeth  (3/09/21) Vaccine received (3/10/21).  No facial reaction existed. On (3/11/21) right side became swollen, with some soreness and itchiness.
Woke up at approx. 4:00 am on 4/22/07 with reddened area at injection site. Site was warm to touch and itched. As of today 4/23/07, area is still red and itches. Has used a "salve" to relieve itching with relief.
H/a in PM; next day 11DEC90 knock dizzy & h/a; 12DEC90 starting to feel better; prescribed APAP;
Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood.  I have never had a bloody nose where it actually was running from the nose.
nausea; vomiting; headache; felt really bad; This is a spontaneous report from a non-contactable Pfizer colleague (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced nausea, vomiting, headache and felt really bad. Patient was going home, and she started to feel nausea, vomiting, and then felt she could not go any longer but then she felt she could still go, so she called her husband and she said that if he could help her. So, then she did not really feel bad and then she went on and on and on and she suddenly realized that she was feeling vomitish. Patient vomited and then she felt headache and so she laid down there and then. Later she called the doctor and the doctor arrived. So that was how sequence of events that occurred. It was reported that now she was feeling better, and she thought that she does not really need help. But She was still going ahead and calling, so that was the whole story. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received first dose of Pfizer vaccine and fainted after walking out of consultation room. Another customer was close by and was able to catch her and prevent her from hitting her head. Patient came to right away and felt fine. Her mother was also present. We provided juice and offered ambulance ride but patient declined. After sitting for a few minutes, she had no other concerns or questions. Stated she was probably just nervous and doesn't like needles.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-NOV-2012 at 17:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as; 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. IT was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. this is one of several reports received from the same source. Additional information has been requested.
Pt received Pfizer x3.  Pt tested COVID + on 8/23/21 and admitted to hospital for COVID on 8/27/2021. Pt received remdesivir and dexamethasone.
Muscle pain; Chills; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- EN6207) via an unspecified route of administration in an unknown anatomical site on 18Mar2021 (at an age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 19Mar2021, the patient experienced muscle pain, chills and tiredness. No treatment was received for the event. The clinical outcome of muscle pain, chills and tiredness were not recovered.  This follow-up (17Jun2021) report is being submitted to amend previously reported information: patient's initial added in first name field in patient tab, final sentence should be No follow-up attempts are possible. No further information is expected. since reporter is non-contactable.  No follow-up attempts possible. No further information expected.
client complained of nausea, tingling and numbness to both arms after receiving 1st dose of Pfizer. Client had been sitting on waiting room approximately 5 mins after vaccine when she alerted EMT she was feeling nauseous. EMT gave emesis bag to client and PHN joined shortly after. Per client has history of anxiety and felt an episode occurring. First vitals at 1100: blood pressure 150/100, pulse 75. Client stated nausea had resolved, but now was starting to feel numbness and tingling to both arms down to fingers. Client stated room felt claustrophobic. Walked client over to patio door for fresh air. Client alert and oriented, history of anxiety, type 2 diabetes and only medication she takes is Metformin. No known allergies. PHN assessed for sensory and motor on both arms. Client denied chest pain, numbness radiating anywhere past shoulders, or shortness or breath. 1105 per client fresh air was helping, could feel her anxiety was improving. 1108 vitals: blood pressure 130/90, pulse 82, oxygen 98%. Per client was feeling better, wanted to leave facility. Client advised be best to complete 30min observation. Client stated she was fine and wanted to leave, had someone waiting outside and would drive. ER precautions given. Client left facility with steady gait at 1110.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 43-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 23-NOV-2016 to 23-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number; WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 23-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.