chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 23 year old female who on 29 Nov 2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil vaccine (yeast) (lot#654389/0961F).  Concomitant therapy included fluconazole which was started on 29 Nov 2006 for a pre-existing infection. On 29 Nov 2006 the patient experienced chest pains described as subclavian and numbing at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered from the subclavian chest pains and numbing at the injection site on 30 Nov 2006. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a nurse practitioner concerning a 24 year old female with no past medical history, who on 29-NOV-2006 at 9:00 AM was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot #654389/0961F). Illness at time of vaccination included vaginal candidiasis. Concomitant therapy included fluconazole which was started on 29-NOV-2006. On 30-NOV-2006, at 12:00 AM, the patient experienced right sided arm numbness along with right sided burning sensation in her chest (described as subclavian). The patient had 5-6 episodes during the night. The patient stated the sensations were resolved by the time she reported it to her physician in the AM of 30-NOV-2006. No further information is expected.
The yellow fever vaccine was inadvertently given intramuscularly not via the subcutaneous route.
Patient was accidently given expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number ag7m9, expiry date 6th May 2022) for prophylaxis.   On 10th May 2022, the patient received Shingrix (intramuscular) .5 ml. On 10th May 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient was accidently given expired SHINGRIX vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received expired SHINGRIX vaccine which led to expired vaccine used.
aching in right side of neck; aching in right shoulder; Soreness and aching in right side of face; ear ache; jaw ache; tooth ache; cheek bone ache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cats. Concomitant medications included collagen peptides (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN) for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported adverse events and included treatment with filed teeth, ibuprofen (MANUFACTURER UNKNOWN) and BENGAY. On an unknown date, the patient underwent lab test which included dental x- rays and results were unknown. The clinical outcome of the events soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event description as reported was updated to aching in right side of neck and narrative was updated as follows: soreness and aching in right side of face, ear ache, jaw ache, teeth ache, cheek bone ache, pain in right side of neck and right shoulder' was updated to Soreness and aching in right side of face...ear, jaw, teeth, cheek bone, as well as in right side of neck and right shoulder'.
Multiple symptoms that had include chest discomfort, palpitations, headache, exercise intolerance, positional changes dizziness, vitiligo,. Chest discomfort, palpitations, postional changes dizziness had resolved.
This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
This writer forgot to dilute the Pfizer vaccine for ages 5-11 and drew up and administered it to the stated patient in her left deltoid. I attempted to contact patient's mother and left several voicemails to return my call about this. Patient's mother has yet to return my call so, I'm unaware of any adverse effects of this vaccine error.
Pain down his right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down his right leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Viral infection. Concomitant products included FAMCICLOVIR for Antiviral treatment.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain down his right leg). At the time of the report, PAIN IN EXTREMITY (Pain down his right leg) outcome was unknown. Not Provided           Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Pt recvd vax on 8OCT92 & devel severe pain in arm, jaw, neck as well as nausea & severe h/a; pt exp flu-like sx w/swollen eyeballs & fever; later exp joint pain & inability to move arm; seen by MD 9OCT92; some tenderness @ site; bruise;
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/15/2021 ACUTE DVT OF RIGHT FEMORAL VEIN I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 9/20/2021 ACUTE DVT OF RIGHT FEMORAL VEIN I95.9 HYPOTENSION 9/23/2021 ACUTE DVT OF RIGHT FEMORAL VEIN J96.00 ACUTE RESPIRATORY FAILURE 10/14/2021 ACUTE DVT OF RIGHT FEMORAL VEIN I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/15/2021 ALTERED MENTAL STATUS, UNSPECIFIED I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 9/20/2021 ALTERED MENTAL STATUS, UNSPECIFIED I95.9 HYPOTENSION 9/23/2021 ALTERED MENTAL STATUS, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/14/2021 ALTERED MENTAL STATUS, UNSPECIFIED I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 10/15/2021 MENINGIOMA, BRAIN I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 9/20/2021 MENINGIOMA, BRAIN I95.9 HYPOTENSION 9/23/2021 MENINGIOMA, BRAIN J96.00 ACUTE RESPIRATORY FAILURE 10/14/2021 MENINGIOMA, BRAIN
Low grade fever (100.1F); Achy joints; headache; sore arm, especially at injection site; sore arm, especially at injection site; muscle aches; This is a spontaneous report from a contactable healthcare professional (the patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 12Feb2021 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: vitamin C and ibuprofen (ADVIL), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 22Jan2021 13:45 (at the age of 44-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 06:00, the patient experienced low grade fever (100.1F), achy joints, headache, sore arm, especially at injection site, and muscle aches. The clinical course was as follows: Low grade fever (100.1 F), achy joints, headache and sore arm, especially at injection site, at 06:00 on 13Feb2021. Low grade fever lasted for about 10 hours, took ADVIL, which brought temperature to normal level (98.8 F). Slight headache still remained on 14Feb2021, but ADVIL relieved that. Fever and muscle aches dissipated by morning of 14Feb2021. No treatment was received for achy joints, sore arm, especially at injection site, and muscle aches. The clinical outcome of the events fever and muscle aches was recovered on 14Feb2021, and for other events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report was received from a health care professional refers to seven unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K024533; expiry: 15-APR-2017) (dose #, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a 80 years old female patient with cataracts both eyes and rheumatoid arthritis concerning herself. The patient's medical history included both hips replaced. The patient was vaccinated with ZOSTAVAX (lot # was unknown) on 30-AUG-2012 to prevent shingles. Concomitant medications included VYTORIN, DIOVAN, ANSAID, ULTRACEF and MEXATE. On 30-AUG-20912 the patient had the ZOSTAVAX and developed redness and swelling at the injection site. The next day it was still red. By the third day 1-SEP-2012, she developed a cough which she still had. She had been calling the doctor's office, but had not been able to get an appointment. No treatment information was reported. Blood work for rheumatoid arthritis every 2 months, the result was unknown. The outcome of cough, swelling at the injection site and redness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
NOSE DRIP; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nose drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210414424.
Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.; Hard Bump on vaccination site on the left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 002B21A and 700M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.). At the time of the report, VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  On an unknown date in November patient experienrd adverse events.
Patient reports developing fever on 7/13. She took 2 doses of Tylenol bid. Rash also developed on right arm on 7/13 and not spreading.  I advised patient to ice the area of it is bothersome.
"Itching, redness, welts, and swelling around lips, neck, and ears" went to ER was given steroids and BENADRYL.
Itchy rash on arms, legs, warm face, rash on abdomen, back, dizzy, nauseated now for 7 days. Rx - Prednisone 20mg, BENADRYL 25mg, Hydrocortisone.
pt recvd vax 26AUG93 & 28AUG93 devel generalized urticaria; by 8SEP93 had recovered;
HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a 38 year old female. 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, expiry: unknown)  dose not reported, 1 total (dose 1) administered on an unspecified date 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 heart attack and died. It was unspecified if an autopsy was performed. It was reported that, "a young 38 year old friends daughter died of a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from heart attack. This report was serious (Death). This case, from the same reporter is linked to 20220750085, 20220750036, 20220750301, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750167-covid-19 vaccine ad26.cov2.s- Heart attack. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable; Reported Cause(s) of Death: HEART  ATTACK
1st week after vaccine administration, developed hives/macular rash, originally around arm then diffuse. Lasted for 2-3 days, no other symptoms.
Initial report received from a health care professional (nurse) on 20 Jul 2010: On 19 Jul 2010, this child received 0.5 ml intramuscular dose of only the MenCWY component of MENVEO (batch number: 100001), instead of being reconstituted with the MenA lyophilized component. No adverse events were noted following this administration. Follow up report received from the health care professional (nurse) on 27 Jul 2010: The doctor's office did not consider this incidence to be an adverse event and did not wish to provide any further information.
This spontaneous report as received from a consumer refers to her 73 years old husband. The patient had no drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) on 16-SEP-2012. No other co-suspects were reported. Concomitant medications included metformin. After receiving the ZOSTAVAX injection, on 17-SEP-2012 the patient had a red rash round the injection site. His rash was a dark red and sore to the touch. It was description as being similar to a welt. The patient stated that the rash was about three inches wide and four-five inches long. The rash lasted for about one and half weeks. The rash was only on the arm. No treatment was given for adverse event. No diagnostics studies were performed. The outcome of adverse events was recovered. The patient did not seek medical attention. Additional information is not expected.
COVID 19; COVID 19; 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 12Feb2021 at 08:30 as dose 1, single (Lot number: EL9269), in left arm, on 05Mar2021 at 08:45 as dose 2, single (Lot number: EN6205), in left arm, on 06Jun2021 at 09:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 18Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not take any other medication in 2weeks. COVID 19 Treatment start date was 15Jul2022. Treatment stop date was 20Jul2022. Indication was treatment of COVID-19. Paxlovid rebound effect 1 or 2 days after completing Paxlovid 5 day regimen. Mild symptoms, felt run down, nasal congestion, chills, left ear canal discomfort. Known allergies was None. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
my arm was sore; stil feeling pain in my hip; stil feeling pain in my lower back; feel like I'm reliving shingles all over again with pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles over 5 months before reporting date).   In May 2022, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm, pain in hip, low back pain and pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in hip, low back pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in hip, low back pain and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had a shot of Shingrix over a week ago manufactured by GlaxoSmithKline. Patient had reaction to shot and still feeling pain in hip and lower back. The patient's arm was sore for short time and then it went directly to that areas. The patient felt like he/she was reliving shingles all over again with pain. Patient had shingles over 5 months before reporting date and that was were all began. The patient's doctor said it was fine to get the shot. The patient asked if they do this for further research. In the meantime, patient would like an answer, as to his/her reaction to shingrix shot. Additional Supportive: The follow-up would not possible as no contact details were available. This case had been linked with the case US2022AMR088947, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR088947:same reporter
approx 36 hours after first pfizer shot i developed stomach pain, sweating, nausea, and then chills...pain continued for the next 4 days continue to get worse...sunday march 28 was admitted to hospital with acute appendicitis...
Approximately 3 weeks after second shot I developed tinnitus. Fully examined by ENT, no hearing loss or other explanation. Tinnitus still ongoing 3 months later.
About 6 days after she received the vaccine, she called us around 3 in the afternoon to report a red triangle that formed a few inches below her injection site that spanned about 2 inches in diameter. She also reported 2 other red spots at the size of a dime, and the injection site started to get red as well.
fever, chills, nausea, vomiting, extreme body pains, pressure & pain in head & eyes,continuous cough,weakness, dizzyness, and feeling faint.
Severe pain in left shoulder near injection site (high on outer back part of arm) that started within a day of administration. Pain is dull and constant and has progressively gotten worse over the past month plus. Reaching across and above my body with my left arm causes excruciating pain and disrupts my daily activities including work, exercise, sleep and showering/ getting dressed. I was treated for bursitis with a 6-day steroid regimen (Prednisone 5 MG) after a follow up appt with her on 12/5/17. One day 2, the pain ceased but it came back even worse before I had finished the doses. Went back to see Dr.  on 12/11/17 and she told me to "schedule ib profen" 3 times a day for 2 weeks to reduce the inflammation and said it was likely tendonitis. I have been taking the ib profen routinely for pain but it has not helped. The pain has now been going on for almost 2 months.
This spontaneous report was received from a physician refers to a 1 year old patient (gender unknown). No medical history was reported. On 23-MAY-2013, the patient was vaccinated with an expired dose of MMR II (lot # 670619/0601AA, expiry: 26-APR-2013). This is 1 of 2 reports regarding twin patients (siblings)received from the same reporter. Additional information has been requested.
burning in her face, legs and feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Patients concurrent condition.; "Vitamin D deficieincy" (ongoing), notes: Patients concurrent condition. The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "not recovered", described as "burning in her face, legs and feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.