chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (confirmed no GARDASIL) (lot # L016428, expiration date: 09-AUG-2017) (dose, route of administration and frequency were not reported). It was stated that the temperature and time frame were 27 deg F for 168 hours. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient came in for COVID vaccine she was in good spirits. After her vaccine, she started off with a small cough that started to increase. She started to cough more at which time I requested my RN to come and evaluate her and Monitor her while I reached out to our ER which is attached. We moved the patient to the sleep lab while waiting for the ER to come up. Patient started complaining she felt that her throat was closing. Her O2 was stable at 98/99. Her HR was over 100 bpm. When the ER team came up and put her in a wheel chair her upper lip was swelling and her arm was blotchy.   Patient did come up a few hours later to schedule her 2nd dose vaccine after she received a high dose IV Benadryl and Pepcid. She is going to speak to her PCP about this reaction and let me us know if she can take the 2nd dose.
3 weeks after patient was given his 2nd Pfizer COVID vaccine he had a stroke.  Onset of stroke symptoms occurred on 5/6/2021. Patient was diagnosed and hospitalized on 5/7/2021.
Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep, results positive 27Sep2021.; Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep, results positive 27Sep2021; This is a spontaneous report from a contactable other hcp.  A 62-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), Via intramuscular route of administration, administered in left arm on 02Mar2021 (Age at vaccination: 62-years-old) as DOSE 2, SINGLE and first dose via intramuscular route of administration, administered in left arm on 09Feb2021 (Lot Number: EL3247) as DOSE 1, SINGLE for COVID-19 immunization. (Vaccination facility: Workplace clinic). No medical history and no concomitant medications were not reported. Patient was not diagnosed with covid prior to vaccination. It was reported as patient Fully vaccinated with breakthrough CV19 confirmed positive case. PCR test performed 27Sep2021, results positive 27Sep2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Sep2021 Nasal Swab.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events VF and Covid 19 and suspect drug BNT162B2 cannot be excluded.
rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on his arm). At the time of the report, RASH (rash on his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Expiration date is unknown for both doses. Both doses received in his upper arm muscle. First one in his left arm (non dominant arm) and second one in the right arm (dominant arm).  The patient does not take concomitant medications.  No treatment medications were provided.   This case was linked to MOD-2021-286925 (Patient Link).
Headaches, irritation, lack of sweat doing exercise, insomnia, redness in all parts of body, numbness left lower foot, tingling sensation, weakness: in all extremities.
5/19/16 Day after injection pt. dev. approximately 1.5 inch area of induration and swelling at site of injection. Also nauseated - vomited x2. 5/20/16 - Tired but no more vomiting. Area of induration still present. 13-year-old received the HPV vaccination yesterday and has developed a firm knot under the site of injection and some swelling. He has also been nauseated today and vomited one time this evening. He is feeling better after vomiting. There has been no fever. Will Rx ondansetron to pharmacy. Will check with Mom in the morning.
Fever, sweating, chills followed by seizure.  Seizure and uncontrollable shaking passed and returned several times overnight.
Fever, Fatigue, Headache, Generalized Body Aches, Cough  Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort.  Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night.   COVID monoclonal antibodies
PPV vaccine given on 2-28-11 pt is complaining of left arm pain since then. No redness or swelling where shot was given.
per patient swollen elbow about 3-4 inch diameter with a spot at the tip like a pimple. still slightly swollen 28 days later
7 days post-vaccination there is a large area on the left arm below the injection site that is red, swollen, and warm to the touch. The PCP has prescribed Prednisone, which at this time has not been started yet.
shortness of breath Elevated troponin Acute respiratory failure with hypoxia Acute hypoxemic respiratory failure due to COVID-19  Pneumonia due to COVID-19 virus sepsis
2 days after the shot I felt malaise and fatigue for a day or so. 16 days after the shot, many of my joints flared up with pain including my wrist/thumb, knee, hip (bursitis), shoulder, lower back for one day.
Client describes rash on face, chest, abdomen on Tuesday, Wednesday morning, difficulty swelling. IV fluids administered at hospital. IV Benadryl and "steroids" administered by ER doctors. Rx's for Prednisone 20mg BID for 5 days given.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions at the pharmacy. Subsequent to patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Right shoulder became extremely painful and I can?t move my arm in any range of motion. I can?t get any relief with any otc pain medicine. I went to Urgent Care on 08/13/2022. I was given a shot and medicine. The shot helped, but only for about 3 hours. The medicine is not helping at all.
This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-JUL-2015, the patient was vaccinated with 10 doses of improperly stored (Oka/Merck) VARIVAX lot # L003774 and expiry date 04-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous case reported by a patient, describes the occurrence of lymphadenopathy (swollen cervical lymph node on the right-side of neck) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (swollen cervical lymph node on the right-side of neck). At the time of the report, lymphadenopathy (swollen cervical lymph node on the right-side of neck) outcome:  unknown. Action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Consent for follow-up accepted. This case linked to MOD-2021-222025 (patient link).
Headache, loss of appetite, numbness in the hands. Occasionally dazed and unbalanced. Numbness in lower jaw and weakness in body.  This long two days   begining day a get vacinated
Client reports taking TDAP 2-3-10. Reports s/s of runny nose and nasal congestion 2-6-10. Reports increasing severity of nasal and head congestion, fatigue, mild fever chills body aches and swollen glands, dizzy. Reports stuffy ears occasional nausea vomiting and diarrhea. Reports has taken over the counter cold medications which she reports have only mildly helped symptoms. Medications take include Nyquil, Dayquil, Theraflu, generic over the counter meds for congestion.
Patient describes Diarrhea, fatigue, headache with no fever, chills. Currently still experiencing fatigue only
PT DID NOT RECEIVE VACCINE FOLLOWING THE USUAL SCHEDULE.  THE FATHER STATES HE WAS INSTRUCTED TO COME BACK IN 6 MONTHS AFTER THE 1ST DOSE.  HE IS CONCERNED THAT HIS SON MUST RECEIVE ANOTHER SHOT.  HE STATES THAT HE IS VERY CONCERNED ABOUT HIS SON'S HEALTH AND WELLNESS AND INSISTS THAT HIS SON WAS ADMINISTERED THE WRONG VACCINE AND THAT THIS SHOULD BE A 2 DOSE SERIES.  I HAVE ASSURED HIM THAT THIS IS OK, HIS SON JUST NEEDS ONE MORE SHOT IN 6 MONTHS AND HIS SERIES WILL BE COMPLETE.  FATHER SAYS THIS IS UNPROFESSIONAL AND SOMETHING MUST BE DONE
This spontaneous report was received from a Licensed Practical Nurse regarding a multiple unspecified number of patients of unknown age and tender. Information on pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD 9lot# M006103, expiry date 01-AUG-2017 (dose number, units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This report is cross linked to MARRS# 1609USA002435 (same reporter link). Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The reporter reported the patient received a first dose of GARDASIL (lot# was not reported) on 10-JAN-2008, a second dose of GARDASIL (lot# was not reported) on 07-APR-2008 and was in the office to receive a third dose of GARDASIL (lot# was not reported) on 22-OCT-2014. No adverse symptoms reported. Additional information has been requested.
itching at the site of the injection; diarrhea; headache; fever; was in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (was in bed all day), DIARRHOEA (diarrhea), HEADACHE (headache), PYREXIA (fever) and VACCINATION SITE PRURITUS (itching at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300042698 and 300042722) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SLEEP DISORDER (was in bed all day), HEADACHE (headache) and PYREXIA (fever). On 10-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of the injection). On 10-Mar-2021, SLEEP DISORDER (was in bed all day), DIARRHOEA (diarrhea), HEADACHE (headache) and PYREXIA (fever) had resolved. On 12-Mar-2021, VACCINATION SITE PRURITUS (itching at the site of the injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Bite Ointment.
Itchy; got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included AMLODIPINE, BENAZEPRIL, HYDROCHLOROTHIAZIDE, GLIMEPIRIDE and DIPHENHYDRAMINE HYDROCHLORIDE (WAL DRYL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
It started with him showing emotional distress. He cried all the time and only sat in one place. His speech started to lose speech. He had learned words and was communicating well with us about his needs to not  being able to say those words and reverted to crying.He had development delays start to show in Gross motor abilities and balance
Body ache; Sore arm, Pain in the legs; Pain in the hips; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PAIN IN EXTREMITY (Sore arm, Pain in the legs), ARTHRALGIA (Pain in the hips) and PYREXIA (Slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concomitant products included OMEPRAZOLE for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), PAIN IN EXTREMITY (Sore arm, Pain in the legs), ARTHRALGIA (Pain in the hips) and PYREXIA (Slight fever). At the time of the report, PAIN (Body ache), PAIN IN EXTREMITY (Sore arm, Pain in the legs), ARTHRALGIA (Pain in the hips) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
Muscle pain; Shivering; Interfering with daily activities; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2021, less than a day after receiving Shingrix, the patient experienced muscle pain (serious criteria hospitalization and disability) and shivering (serious criteria hospitalization and disability). On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the muscle pain and shivering were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the muscle pain, shivering and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. Extreme muscle pain and shivering following 1st dose of Shingrix.  The events ere unresolved and interfering with daily activities.  The patient also bounded with wheelchair.  Several emergency room (ER) and hospital visits required.  Medical facilities also visited by the patient.  Lab work and cat scans performed. Only diagnosis ascertained was muscle pain. The reporter consented to follow up.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient presented t the ED with chest pain, fever and shortness of breath. This was following the 2nd dose of COVID-19 vaccine. She was in her usual state of health prior to vaccine. She had anterior chest pain that started at 1:00am on 2-12-21 along with fever of 100.4, nausea, and HA.  Denied loss of taste, smell. No cough or upper respiratory congestion.  Pain and local inflammation at the injection site.  Also reported  right leg cramping and right leg edema. She reported she never had a DVT or PE but has Factor V Leiden.  Patient felt that her dyspnea was not related to her asthma, that it felt different.  ROS:  Positive for fever, SOB, wheezing, nausea, myalgias, HA Physical exam:  No acute distress. Tachycardia, No respiratory distress. Breath sounds no stridor, wheezing, or rhonchi. No edema in right lower or left lower leg.
Patient developed a red and warm area to the left arm on 1/20/15.  patient developed 100.8 temperature early morning 10/21/15.  The redness and warmth has also increased since 10/20/15.
Customer came to pharmacy 12/20/13 stating he had swollen arm since receiving vaccine, no other symptoms were reported.
On 08/07/2001 the patient noticed swelling of his left arm (deltoid area), tenderness, and hot to touch. The patient returned to the Health Dept to have his arm examined. The patient had a 3-4" area hardened, erythema, and hot to touch, along with 1/2 x 1" bruise at the site of injection.
Vaccinator administered patient a booster dose (0.25 ml) instead of a full dose (0.5 ml) of moderna COVID vaccine for patient's 1st dose.
large circular rash in the area of injection and then another circular rash just below it. Red, itchy, swollen and hot to touch.  Saw it first on Wed April 5th , then it progressively got larger the next day. On the 3rd day (today) it's not so bad. I have rubbed the area with an ice cube to cool it down.  That's all.
Rash developed from top of shoulder to to top to elbow, raise, blotchy and itchy. Pt reported this AM it is the size of two 50 cents pieces now
Patient received JANSEN (Johnson and Johnson) COVID 19 vaccine (Lot#1805022) on 06 March 2021.  Patient scheduled appointment for today (05 May 2021) to receive Moderna COVID19 vaccine (Lot #009C21A).  Vaccinator asked the patient the standard screening questions before administration, but did not verify in patient information VAMS prior to Moderna administration.  Patient did not disclose having previously received Jansen COVID19 vaccine.  Following Moderna vaccine administration,  Vaccinator informed vaccination lead of the incident. Vaccination lead spoke with patient regarding the incident and contacted Safety Officer.  Patient reported history of ?long COVID?.  Site Director was brought into the conversation to further inform the Patient of county protocols regarding COVID19 vaccine administration.
Exremely fussy, fever 102.3 A; temp to 105 had febrill fit;
NO ADVERSE EVENT; Patient was vaccinated with a dose of Proquad that had a temperature excursion; This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concurrent therapies were not provided.   On 05-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA; 0.5 milliliter, lot # S027465 expiration date 02-MAR-2021) for prophylaxis. No adverse event or product quality complaint was reported.     The temperature excursion lasted 14 hours at a temperature of 5.7 F and was due to a data logger issue.  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # reported as S0317056 expiration date 06-APR-2021 was also improperly stored.   Lot number S0317056 is an invalid lot number for Measles, mumps, rubella and varicella (oka-merck) virus vaccine live.