chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to one-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045392, expiry date: 17-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
9:50 client c/o nausea after vaccine. Placed on floor BP 169/100. client states I have high BP  high BS school nurse to follow up with monitoring BP and BS. Client did not have breakfast. Peanut crackers and juice given to client states I feel better. Returned to class.
Diagnosed with COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Diagnosed with COVID) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). At the time of the report, COVID-19 (Diagnosed with COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) diagnosed with COVID..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.     This case was linked to MOD-2021-249750 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received contains significant information as outcome updated to recovered. Second dose case was added in additional information.
Cellulitis in arm of the injection, red, hard, inflamed injection site appears to have had a blister that popped. Pt experienced migraine w/aura; extreme fever, myalgia that caused loss of work.
left injection site arm turned red/Redness lasted for 10 days; My left arm became red and itched; area of redness extended 5 inches from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 027A21A) for COVID-19 vaccination.     No Medical History was provided by reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (left injection site arm turned red/Redness lasted for 10 days), VACCINATION SITE PRURITUS (My left arm became red and itched) and VACCINATION SITE SWELLING (area of redness extended 5 inches from the injection site) outcome was unknown.            Treatment medications were not provided by reporter.   This case was linked to MOD-2021-370313 (Patient Link).
Experiencing some "fussiness" and a bruise with redness at injection site right deltoid area where DTaP administered. Bruise and redness 3+ inches per mother per telephone call. Mother did not feel necessary for MD follow-up, will monitor child's arm.
Wrong vaccination administered to a pediatric patient due to employee error. Patients mother has reported no current symptoms.
Allergic/adverse reaction to vaccine administration - given yellow fever and typhoid 45 minutes prior to onset of multiple pruritic 2-4mm wheals.  Treated with benadryl and given short course of prednisone.  No respiratory symptoms.
I recently had some blood tests and had an antiphospholipid antibody syndrome; Maybe a bit of lethargy/ very mild; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) (seriousness criterion medically significant) and LETHARGY (Maybe a bit of lethargy/ very mild). At the time of the report, ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) and LETHARGY (Maybe a bit of lethargy/ very mild) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: had an antiphospholipid antibody syndrome (abnormal) had an antiphospholipid antibody syndrome. On an unknown date, Protein S: very low protein s (Low) very low protein S.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Approximately 4:30 begin notice it was difficult to pull in a breath of air "like I was breathing through a tube".  As time went on she describes it that she couldn't get a deep breath.  At approximately 4:36 pm used her Albuterol 90 mcg ( 2 puffs) inhaler.  It did not give her any relief.  At 4:55 took 50 mg of Benadryl. She noticed mucus forming in her throat and tightening in throat.  At Approximately 5:15 EMS came to evaluate.  BP elevated,  171/110, 174/108, 166/127. while being evaluated she felt like the benadryl started to kick in and she started to feel a little better.  Through the night she started to feel somewhat better, headache and some pain in the back of her neck and knee pain was noted in the evening.
Constant nausea and belching. Cola and OTC painkillers had no effect. Gone after 2 1/2 days.
On the right forearm there is a red purple patches consistent with ecchymoses or recent trauma. Diffuse papular erythematous eruption on the bilateral flanks from the spine to the midline of the abdomen. Hyperpigmentation in a photo distribution consistent with sun damage and solar lentigo as well as hyperpigmention and erythema consistent with recent sun damage and solar lentigo on the face, V of the chest and bilateral upper/lower extremities. Traimcinolone cream was prescribes at OV.
RECEIVED VACCINES ON 10/13/08. RAN FEVER OF 102 DEGREES TIMES 2 DAYS, THEN BECAME DIAPHORETIC. APPOINTMENT WITH DOCTOR 10/16/08 AND SUGGESTED VAERS REPORT.
7-22-13 Patient was seen in the office CC: was a rash on the right side. Treatment ZOVIRAX 3.5.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The patient had mild soreness and erythema. The healthcare professional stated vaccines were administered at two different pharmacies, thus did not have expiry date or lot numbers. For tolerance to 2nd dose refer case US2018GSK163609.
Vesicles erupted on 9/14/00 on face, back and stomach followed course of disease and more erupting for 4 days, originally. Now crusted. No fever. Itchy. Treated with oatmeal baths and Benadryl at home until all are crusted.
This spontaneous report was received from a pharmacist, and refers to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with PNEUMOVAX23 for prevention of pneumococcal disease. On unknown dates, the patients experienced erythema, swelling and warmth. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA006827.
She had a seizure 7 days after shot and then started to break out with the  mumps all ariund her face
PATIENT HAD A CHANGE IN SPEECH ACCOIATED WITH INCREASED BLOOD PRSSURE ON 9.23.2022
Vertigo local - redness, hot/warm to the touch, pain at injection site, swollen.
Pt states, 2-3 hrs after vax, her L/arm started swelling from shoulder down to her fingertips & light swelling around her neck. Seen by Dr on 12/9/99 & her B/P was elevated, 180/100. As of 12/10/99, sx's gone, except for swelling of L/hand.
Information has been received on 04-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 62 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 24-FEB-2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2010, 2017 and 2018, the patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
pt presented at the pharmacy on 03/17/21 to say after getting her second dose of the moderna covid vaccine on 02/24/21, she fainted at the entrance of Dr's office less that one hour afterwards (she waited at the pharmacy for 15mins after receiving the vaccine) per pt she was taken by ambulance to the hospital were she spent 3 days in the ICU after she was released under the care of her family member. Pt stated that she did not experience any other symptoms.  She  stated that the Dr didn't think it was related but she thinks it is. she is feeling a little better now
Pain on lumbar spine to sacrum. Positional Burning Neuropathy sensation in both feet.  Positional numbness in both hands.  Sensation in both feet and hands fades after some time with gravitational assist.  (Standing or Sitting)
I am a travel RN and received the vaccine while working  in TX.  By 9 :00 am,  I had a fever of 101 with body aches, chills, nausea, fatigue and abdominal cramps. By 11:00PM,  my fever was 102.5 and I was in so much pain. I finally did take some medicine.  About 24 hours after, the lymph nodes were swollen in my right arm pit.  I couldn't turn my head because of the swollen lymph nodes in the right side of  my neck.
10/30/2022 I was exposed to COVID a few days previous. I had mild congestion and a little bit of fever. I tested positive for COVID. This lasted for several days. 10/31/22. On 11/1/22 my doctor recommended PAXLOVID and I started taking it that day. By 11/4/22 I began feeling better. I still have a little congestion, but am back to my normal self.
running a fever; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age (age: 19, units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 09Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother stated that the patient got the second dose of the Covid-19 vaccine on Saturday, 09Jan2021. The patient has been running a fever since possibly Saturday night 09Jan2021, but definitely since Sunday morning. The fever was mostly in the morning and at night around 7-8 pm. Fever in the morning lasts until 10 -11 am. The mother added that today was the first day the fever has lasted all day, and the patient had the fever at 3PM. The mother wanted to know if this was a typical response to the vaccine (i.e. the duration of the fever). The mother was concerned about the duration of the fever and she has given the patient ibuprofen and Tylenol. The mother asked for herself if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The mother was responded per the interim guidelines, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time." The mother was told to discuss this with her healthcare provider. The outcome of the event was not recovered.  Information about the lot/batch number has been requested.
I got both Pfizer vaccines 8/6/21 and 8/27/21. My hair began falling out Novembe 4th. I have now lost about 60% of my hair. I have never suffered from hair loss in my life prior to this. The vaccines are what triggered my massive hair loss.
Headache; Muscle Ache; Fever; extremely tired sleeping most of the day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) in a male patient of an unknown age 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 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Muscle ache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Muscle Ache), PYREXIA (Fever) and FATIGUE (extremely tired sleeping most of the day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 (High) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were provided.
In the patient's medical chart, the reaction noted by a nurse on 1/17/2019 was, "numbness". The patient's last documented influenza immunization was 12/12/2017 and for this reason this was the date that was entered for this report. The patient was unable to be interviewed as there were patient care activities performed when attempted for an interview. This report is filed solely based on the information included in the chart as influenza virus vaccines were documented in his chart as an allergy with the reaction, "numbness" on the noted date as described above.
Began with scratchy throat that progressed into coughing so hard that she broke a blood vessel in her eye.  Went to physician received medication 7 days post vaccine went back to physician because still coughing and dx with pneumonia.
Patient  was feeling dizzy,  light headed, and was sweating.   Symptoms passed after about 20 minutes.  Blood pressure within normal limits.  Do problems with breathing
This case involves a 17-year old male patient who received 3 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], not showing any adverse reactions (extra dose administered). Past vaccination(s) included MENACTRA (First dose at the age of 11 years and second dose at the age of 16 years). Medical history, past medical treatment(s), concomitant medication(s) and family history were not provided. On 01-Jul-2021, the patient received 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U4648AA and expiration date: 25-Apr-2015 and lot number: U6951AA and expiration date: 06-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination. It was reported as " a nurse (RN) stated a male patient received 3 doses of MENACTRA and asked if there are any concerns or anything to be aware or on the lookout for. RN stated the first MENACTRA dose was administered at the age of 11 years old; the second was administered at 16 years old and the 3rd dose was administered at the age of 17 years old. Nurse stated the patient has not shown any symptoms of adverse reactions. Nurse provided the lot & exp. dates of the first and third Menactra doses; Nurse stated there is no record of the lot/exp. date of the second dose. MIA attempted to warm transfer the nurse to a HCP. However, no HCP was available. Nurse requested a call back or an email reply tomorrow; she will be available 08:00 - 16:30. Outbound call made on 08Jul2021, 10:26 Spoke with nurse who states they thought the patient needed the second dose and when the Menactra injection was given he then presented paperwork to show he had already had the second dose. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age.---SF male dob: Jul 24, 2003". It was a case of actual medication error due to extra dose administered (latency: same day). At the time of report, no adverse event reported. 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.
On 1/14/16, pt reported ringing in the ears beginning on 1/13 at about the time he was leaving the store. Reported that went home and went to sleep. In morning, ringing continued and also had a dizzy spell that went away about 30 minutes later.
Red v mark at the site of injection that has a lump in the spot. And my arm is still sore
Chest pain for four hours after vaccine and worsening heart palpitations. No doctor was seen.
Information has been received from a registered nurse concerning a 1 year old male patient with no allergies who on 11JUL2003 was vaccinated in the lower right thigh with a doe of varicella virus vaccine live. Concomitant vaccinations included a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) in the left thigh and a dose of Haemophilus B conjugate vaccine (ACTHIB). There was no other concomitant medication. By 20JUL2003, the patient had developed a 102 degree fever and spots on his back and belly. Unspecified medical attention was sought, but no other studies were performed. At the time of the report, the patient no longer had a fever and was "recovering with sequelea" from the spots on his back and belly. A product quality complaint was not involved. Additional information has been requested.
A report was received from a health professional on 17Oct02, concerning a 2 vaccinees of unk demography who experienced shortness of breath after receiving Fluvirin on an unk date. On the unreported date, the vaccinees experienced shortness of breath after receiving Fluvirin. No  other information was available from the reporter. The reporter has assessed the relationship of the vaccine to the event as probable. Ref: PJP200200572, PJP200200573.
Patient experienced syncope, pale and clammy skin. Possible short small seizure. Patient was on empty stomach did not eat breakfast and or lunch. Patient passed out from the chair and possibly hit his head on the floor