chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 11-JAN-2017,  the patient was vaccinated with M-M-R II, subcutaneous for prophylaxis (lot # and expiration date unknown).  Other suspect therapies included LIQUID PEDVAXHIB. On 11-JAN-2017, the patient was vaccinated with M-M-R II which was reconstituted with LIQUID PEDVAXHIB (considered as experienced product preparation error).  The reporter had training to administer vaccines and stated "that because in the military, there is no licensed healthcare prescriber on site as correspondence contact". No adverse effect was reported. No further information is available.  Additional information has been requested.
Patient died within hospice care. He tested positive for COVID on 8/22/2021. Hospice notes submitted into data base.
Bilateral leg swelling, ED visit for shortness of breath and wheezing, received nebulizer treatment
Fever running upwards to 100.; Muscle aches; Could not sleep night of shot; This is a spontaneous report from a contactable other healthcare professional (patient). A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. The patient had no medical history and did not have any allergies to food, medications, or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Mar2021 at 20:00, the patient experienced fever and muscle aches. Fever was running upwards to 100 (unspecified units) and the patient could not sleep at night of shot. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19.  No treatment was received for the reported events. The outcome of the events could not sleep at night of shot, fever and muscle aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner referring to multiple unknown patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # M032148, expiration date: 18-APR-2019; lot# M036057, expiration date: 18-MAY-2019; dose and route unknown) for prophylaxis. The PEDVAXHIB was stored under temperature between 32 Fahrenheit and 36 Fahrenheit for 44 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002539.
pt recvd vax & w/in 48hrs exp herpes zoster on lt should which spread under lt arm;seen by MD;tx Famvir x 7 days;sx completely resolved 3wks p/total eruption;
threw up; fever; achy; headache; has no energy; hasn't eaten anything either/ not eating very well; she had cramps; Diarrhea; just tired/very tired; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (consumer's daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient threw up, had fever, was achy, and had a headache. Reporter stated that, they (reporter and her daughter) hadn't been anywhere to even pick anything up. She stated her daughter (patient) was better but had no energy but hasn't eaten anything either. Her daughter (patient) was worse off than her (reporter) she had cramps diarrhea, fever and nausea. Patient was achy too. Later, reporter clarified that, her daughter (patient) was not nauseous, she was just saying, she feels no energy and was very tired. Her daughter (patient) told her (reporter) that, she was feeling better but she was not eating very well and she was just tired and had no energy. The clinical outcome for the events was recovering except for events, has no energy, hasn't eaten anything either/ not eating very well and just tired/very tired was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
11 YO MALE GIVEN A DTAP.  HE REPORTS SLIGHTLY SORE ARM ONLY.  MOM MASSAGED ARM.  HE WAS ABLE TO PLAY AS USUAL.  NO UNUSUAL ADVERSE REACTION REPORTED.
persistent high pitched cry >4hr parent reports that episodes occurred up to 1wk post vax;
Deviation from recommended age group during a hospital hosted covid vaccine clinic. The hospital's Chief Medical Officer contacted the patient's primary care physician and the patient/parents were contacted as well.
Persistent (R) deltoid pain 6 wks after vaccine no neurological strength deficit. 50% improved.
Dizziness, Tachypnea, baseline sob and dizziness got worse after vaccine and persist 2 weeks post vaccine; also noticed sore breasts  Narrative:
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down.  She went to see her doctor last week and was treated with benadryl.
Affected area was red; Itchy around her eyes; Rash on face; Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach); Itchy face; Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and ERYTHEMA (Affected area was red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)) and EYE PRURITUS (Itchy around her eyes). On 12-Feb-2021, the patient experienced ERYTHEMA (Affected area was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on face), RASH (Rash on neck/Rash on chin/Rash around her eyes/Rash on trunk (lower stomach)), PRURITUS (Itchy face), PRURITUS (Itchy neck/Itchy chin/Itchy around her eyes/Itchy arms (from her elbow down to the wrist)/Itchy trunk (lower stomach)), ERYTHEMA (Affected area was red) and EYE PRURITUS (Itchy around her eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
pt had complete physical exam 27AUg97;immun given that day;that noc had temp tx w/APAP;4 days p/vax pt devel bells palsy 31AUG97;seen @ office 1SEP97 dx w/bells palsy;
noted several small pimples like scattered on abd, 2-3 pimples on arms;no redness around pimples-no itching;
A non-serious report of "six patients received expired FLUMIST "was received from a nurse concerning a four-year-old (unknown gender). The patient's' medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. This case is submitted in accordance with MedImmune's post-markings commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
left breast clogged for about 2-3 days left buttock/upper thigh broke out in hives left arm is still a bit sore
I had itching and redness and knots that formed in my left leg.  The knots were at the site of a vericose vein.  I sought tx at an ER on 12/26 to ensure it was not a blod clot.  I followed up with my family dr on 1/4/2021 (When her office reopend) and was diagnosed with Superficial Thrombophlebitis. The knots remain in my leg.  The redness has mostly gone away.  My PCP felt as I recenlty had covid, the vaccine likely flared up the inflamation in my body and caused this condition.
I received the second Pfizer shot on March 1st. My initial reaction consisted of a couple of days of flu-like systems that abruptly went away. Then a week ago I came down with what appeared to be an intestinal bug. My subjective sense is that my immune system got confused and is now mounting random immune reactions  - chills and fever, severe back pain, diarrhea, etc.
Patient received pfizer vaccine as the second dose instead of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna). On 17-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received pfizer vaccine as the second dose instead of Moderna) 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.   Concomitant product details was not reported.  Treatment details was not reported .
Received Menactra on 8/20. Red, hot, swollen, and painful at injection site. Red area approx. 6 cm in diameter. Dx with cellulitis treated with clindamycin 150 mg.
STIFF NECK (CANT TURN HEAD TO THE RIGHT); RIGHT ARM PAIN; 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: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 16-MAR-2021 18:39 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stiff neck (cant turn head to the right). On 17-MAR-2021, the subject experienced right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck (cant turn head to the right), and right arm pain. This report was non-serious.
From the doctor that saw me in the ED: Patient received the second dose of her Covid vaccine on January 12.  5 days later, on January 17, she had onset of a diffuse pruritic macular papular rash on arms, chest and back and mildly on her face.  2 days ago, she was seen in urgent care and given prednisone and antihistamines.  She has had no improvement.  No mucosal involvement.  No fevers or chills.  No joint or body aches.  No new exposures, medications.  She is the only one in her house with the symptoms.  She works as a nurse, but has had no known exposures.
Information has been received from a consumer, for the Pregnancy Registry for VARIVAX (Merck), concerning his daughter who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). The consumer stated that his daughter was 6 months pregnant when she received VARIVAX (Merck). No adverse event was reported. The patient sought unspecified medical attention. Follow up information received. Reporter information was updated. Additional information is not expected.
Developed cellulitis on lower legs after each administration of the Hepatitis A vaccine. Vaccine given on 10/28/14-rash developed on 11/4/14 on left shin was cellulitis. 5/5/15 Hepatitis A #2 dose given. Rash lower legs developed 5/15/15/cellulitis.
Vaccine given to patient and the vaccine had expired 4 days before. The vaccine expiration date was calculated incorrectly. The patient had no signs or symptoms and the mom was advised if any questions or concerns to call.
chills; muscle aches; headache; fatigue; nausea; didn't feel well; This is a spontaneous report from a contactable consumer. A 36-year-old female patient (pregnant: unknown) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, muscle aches, headache, fatigue, nausea in Jan2021 as a result of her second vaccination. The patient didn't feel well in Jan2021 after her second vaccination on 13Jan2021. It was unknown if treatment for the adverse events. No Covid prior vaccination. It was unknown if Covid tested post vaccination. The outcome of the event didn't feel well was unknown, of the other events was recovering.  Information on the lot/ batch number has been requested.
Pfizer COVID Vaccine was not diluted prior to administration. 0.2ml of undiluted vaccine was administered. No reaction/side effects as of 07/28.
Pt recv vax on 3/23/99; on 4/1/99 pt exp headache, right side abdomen pain to back
8/22/12 - Received vaccines - HIB, PCV-13 and ROTARIX -> stools that PM became green, looser and had blood. Maternal milk free diet, ZANTAC, GI ref.
64 year old female, with a history of diabetes and hypertension. Patient is taking lisinopril, and is allergic to sulfa drugs. 11:25am Patient complains of being dizzy after receiving the vaccination. Patient stated that she is diabetic and only ate yogurt this morning. Vitals were taken, BP 90/58, HR- 70. Patient was observed for 30 minutes. 11:45 vitals were 102/66, HR 86, RR 16. Patient had water and pretzels while she waited in observation. Patient stated she felt good and was no longer dizzy at discharge.
Patient has had swelling at site of injection for 10 days.  For the last 3 nights he has been having chest pain, back pain and shortness of breath with dizziness.
Myalgia, Fever, chills, sweat, swollen glands, fatigue Narrative:
Graves' Disease related to the vaccine. It does need to be treated medically at this time and over the long run we'll try to push this into remission.    From the patient: I have generally not felt well since my Moderna Covid booster on 11/19. I had a 99 degree temp for a few days after the booster. My normal temp is closer to 97.4. Since then a few new symptoms have appeared which may be coincidence. I noticed some hair loss near my bangs over the last 1-1.5 years. Otherwise, most of these symptoms are new. I'm experiencing: * Scratchy voice (which may relate to some neck muscle tightness and stress), occasional coughing jags * Some nasal congestion and occasional cluster of sneezes * 1-1.5 degree temp usually around 2:30 or 3:00 pm (sometimes all day) 3-4 days per week, usually with a slight headache. Temp often ends around 7:00 pm. * TOP CONCERN #1 Less breathing capacity while walking, water aerobics. Monday I could not continue walking without a rest at about 2,000 steps at a slow pace. My heart was pounding. * Winded after bending over or doing physical work * A little dizzy after doing something while bending over, rotating from one counter to another in the kitchen in a circle * TOP CONCERN #2 Swollen ankles only at first, then included tops of feet and toes, then wrist under watch band on left arm, tighter ring on right ring finger, calves. Used to happen only after (Privacy) restaurant food starting about 1.5 years ago. At that time, an echo was done and all was well * Lower energy and some brain fog -- not finding words or hard to concentrate * Emotionally feeling concerned, drained and down  I started out with acupuncture treatment and then brought in my doc since the symptoms are not improving and in the last 2 weeks have worsened.
One hour post vax, the pt experienced redness and itching at the site which continued to increase. The are is approximately 7 inches of redness and itching. No systemic symptoms. Treated with Benadryl and cool compresses. Has a history of milder reaction to MMR and DtaP.
WORSENING OF BRUISES ON TOP OF HER ANKLES AND DOWN TOWARDS THE TOES AND SPORADIC; LIGHT SENSITIVITY IN HER EYES; ADMINISTERED JANSSEN VACCINE AS A SUBSTITUTE 2ND DOSE VACCINE AFTER MODERNA VACCINE; OFF LABEL USE; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have history of drug abuse/illicit drug use. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On AUG-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Normal, Haemoglobin (NR: not provided) Normal, Lymphocyte count (NR: not provided) Normal, Monocyte count (NR: not provided) Normal, and White blood cell count (NR: not provided) Normal. On 27-AUG-2021, the patient experienced light sensitivity in her eyes. On 27-AUG-2021, the patient experienced administered janssen vaccine as a substitute 2nd dose vaccine after moderna vaccine. On 27-AUG-2021, the patient experienced off label use. On 27-AUG-2021, the patient experienced tiredness. On 29-AUG-2021, the patient experienced worsening of bruises on top of her ankles and down towards the toes and sporadic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light sensitivity in her eyes on AUG-2021, and tiredness on 29-AUG-2021, had not recovered from worsening of bruises on top of her ankles and down towards the toes and sporadic, and the outcome of off label use and administered janssen vaccine as a substitute 2nd dose vaccine after moderna vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (lot number reported as K008820 and expiration date 19-JUN-2016, route and dose were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.