chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative, notes: Rebound after 2 negative tests; (Sep2022) Negative, notes: Rebound after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound after 2 negative tests. Fever, stuffiness, earache, body aches. COVID-19 Treatment: Paxlovid treatment start date :31Aug2022 and treatment stop date :05Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 29JAN97 & 3FEB97 pt devel a rash consisting of more than 25 lesions;
Covid Arm Rash right below injection site- approximately 2 1/2 inches x4 inches rectangle shaped- reddened/ slightly raised, itchy, painful to touch Have pictures if needed
Pt developed chronic muscle disease of arms, legs, hands and feet. Pt also had Lymerix vaccines on: 4/12/99-LY104A2 and 5/13/99-LY116A2. Per doc 205270: same, still pain in arms and legs; still on prednazone. The annual follow-up states "still muscle pain and extreme fatigue. Still on prednazone."
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose number was not reported), 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reports that on 01-AUG-2014, a ZOSTAVAX that underwent a temperature excursion was administred to five patients. (MARRS 1408USA006489, 1408USA006490, 1408USA006491, 1408USA006492 and 1408USA001809). This case is one (1) of five (5) reports from the same source. Additional information has been requested.
aches in muscles & joints;red hot feeling in knees;itchy, swelling, redness around POI;, runny nose, nasal congestion, weakness, fatigue, gastric upset;
Not feeling well/not expecting to feel the way he feels; Tired; Confused (meaning he could not put thoughts together); Moody; Throat swelled up; Could not breath; Started to sweat; Eyes hurts; Joint hurts; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody), PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath) and HYPERHIDROSIS (Started to sweat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE, LOSARTAN and SPIRONOLACTONE for an unknown indication.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts) and ARTHRALGIA (Joint hurts). On 04-Oct-2021, the patient experienced CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)), MOOD SWINGS (Moody) and FATIGUE (Tired). On an unknown date, the patient experienced MALAISE (Not feeling well/not expecting to feel the way he feels). At the time of the report, CONFUSIONAL STATE (Confused (meaning he could not put thoughts together)) and MOOD SWINGS (Moody) was resolving and PHARYNGEAL SWELLING (Throat swelled up), DYSPNOEA (Could not breath), HYPERHIDROSIS (Started to sweat), EYE PAIN (Eyes hurts), MALAISE (Not feeling well/not expecting to feel the way he feels), ARTHRALGIA (Joint hurts) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Three days after vaccination patient noted that his thyroid medication was not working.  No treatment information was reported.
Headache (7/10 pain scale), neck pain, fever 101.4, pain at injection site (right leg) (8/10 pain scale) feet tingling, joint tenderness, muscle tenderness, stomach ache.
administered dose past the 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received and contains updated reporter's email
Got sick 36-48 hours after vaccine with fever 103, sores in mouth, swollen gums, sore throat, sweating, HA nausea, vomiting. Went to ER on  2/1/05 and was sent home. Elevated LFT on 2/5/05. Saw a dentist for mouth pain and was treated with PCN. She was sick until about 2/9/05. Cancelled her planned trip overseas.
ON 8/31/95, pt was vaccinated with 1 dose of varicella virus vaccine live. In utero VZV exposure was denied. On 12/1/99, the pt developed an itchy rash on her left arm. Gradually, the rash spread from her shoulder to her thumb and new lesions are still developing. The rash was described as linear and in clusters. There were "numerous" lesions. "Tens to low hundreds of small vesicles" were reported. Prior to onset, the pt complained of a sore and itchy arm. The pt presented to a doctor on 12/15/99, and was dx'd with herpes zoster. It was reported that > 1 month, post vax, the pt was prescribed Intal and at the time of this report, the pt's symptoms persisted. Follow-up information reported that a large swab of the herpes zoster was obtained on 12/15/99. The pt has recovered. Follow-up information reported that the final PCR results for the specimen revealed wild-type VZV. Additional information has been requested.  Follow up information has been received from a physician concerning an 11 year old female student with a history of mild asthma when she was younger and hay fever, who on 31Aug1995 was vaccinated in the arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The child was reported as healthy. In utero VZV exposure was denied. Concomitant medication included albuterol sulfate (Ventolin) prn. 09Nov99 (also reported as 01Dec99) the pt developed an itchy rash on her left arm. Gradually, the rash spread from her shoulder to her thumb, and new lesions were still developing. The rash was described as linear and in clusters. There were numerous lesions. Tens to low hundreds of small vesicles were reported as WNL. Additionally, prior to onset of the event the pt complained of a sore and itchy arm. The pt presented to a physician on 15Dec99 and was diagnosed with herpes zoster. On 15Dec99 a large swab of the herpes zoster was obtained. The final results for the specimen revealed wild type VZV. Subsequently the pt recovered. It was also reported that greater than one month post vaccination the pt was prescribed cromolyn disodium salt (Intal). No further information is expected.
NAUSEA UPON INJECTION duration 1 hour DYSTONIA OF FOOT  5 min duration 2 1/2 hr. after injection  DYSTONIA OF NECK WRYNECK 1 hour 15 min after injection  HIVES FACE / NECK 6 hr. after injection
Pt received the second dose of Pfizer vaccine on 5/5/21 815 am left arm, on 5/7/21 pt experienced some chest pain which got worse on 5/8/21 with chills, body ache. Then on Monday went to see cardiologist, labs, cat scan, echo & ekg  were performed.
arm was painful; rash is bumpy; Rash is a little hard; red circle around the shot area - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle around the shot area - right arm), VACCINATION SITE PAIN (arm was painful), VACCINATION SITE RASH (rash is bumpy) and VACCINATION SITE INDURATION (Rash is a little hard) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the shot area - right arm), VACCINATION SITE RASH (rash is bumpy) and VACCINATION SITE INDURATION (Rash is a little hard). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was painful). On 22-Jan-2021, VACCINATION SITE PAIN (arm was painful) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red circle around the shot area - right arm), VACCINATION SITE RASH (rash is bumpy) and VACCINATION SITE INDURATION (Rash is a little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Information has been received from a registered nurse concerning a 3 year old male who was vaccinated subcutaneously one time with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the patient experienced mild case of varicella. The patient was seen in the physician's office. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Swelling/Redness to face; hives 10:00AM treated with Benadryl. Later- went to ER d/t no improvement and now N/V/D received steroid injections and Zofran per mom.
Information has been received from a 66 years old female patient who with sulfonamide allergy concerning that in 2007 she received the vaccine for pneumonia (manufacturer not specified; therapy route, site unknown). Right after the injection her arm started swelling up. It wasn't just swollen at the injection site, but rather her whole arm was really swollen. The arm was not painful; it was only painful during the injection. She bought medical attention and about a week after getting that vaccine the patient recovered. No further information is available.
Broke out with hives all over her body, including her arms, knees, elbows, and arms.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.). At the time of the report, URTICARIA (Broke out with hives all over her body, including her arms, knees, elbows, and arms.) had not resolved.            No concomitant medication was taken. Treatment medication was not provided.
Extreme tiredness/fatigue set in six days after the shot, and lasted approximately one day. This is a spontaneous report from a non-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: EW0171) via an unspecified route of administration in the right arm on an unknown date in May2021at 14:30  (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced extreme tiredness/fatigue set in six days after the shot, and lasted approximately one day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme tiredness/fatigue was recovered on an unknown date in May2021. No follow-up attempts are possible. No further information is expected.
Arm muscle pain, leg muscle pain, back pain, headaches, metallic taste in mouth : all lasting up to 2 weeks
Information has been received from a physician concerning an 18-week-old underweight infant who on 17-JUL-2006, at 1500, was vaccinated by mouth with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653754/0139F).  Concomitant vaccinations administered on that same day and time included the second intramuscular dose of hepatitis B vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot#653274/1072R), the second intramuscular dose of diphtheria toxoid (+) pertussis acellular (unspecified) (+) tetanus toxoid (Lot#C2431AA), the second intramuscular dose of poliovirus vaccine inactivated (IPOL) (Lot#X1166) and the second intramuscular dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08683A).  There was no other concomitant therapy or illness at the time of vaccination.  The physician reported that the on 18-JUL-2006, the patient developed severe diarrhea that was bright green and watery with a foul odor.  It was noted that the patient was having about 1-2 episodes per day. The patient was seen by the physician, but no laboratory/diagnostic tests were performed.  At a follow-up on 07-AUG-2006, the patient was still having problems.  On 09-AUG-2006, the patient was noted to be recovered.  Additional information is not expected.
it feels like there is nick there in my veins, it is burning; having a burning sensation; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (solution for injection, Batch/Lot No: EN0178), via an unspecified route of administration on unspecified date at unknown dose number, single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that patient was not having a very good reaction, it felt like there was nick there in veins, it was burning (was having a burning sensation) and it was not all the time, it was just off and on an unspecified date. The patient stated considering going to an ER or urgent care right now and spoke with Pharmacist and was checking the dosage. Patient was told by the technician who gave the vaccine that it was 3 ml and then Pharmacist said that it was 0.3ml, the standard dose and then the lady that answered the phone said patient was given 0.3 ml. The outcome of the event was unknown.  Follow-up attempts are needed. Further information has been requested.
Unilateral sudden sensorineural hearing loss with tinnitus. Onset of symptoms 6/11/21
Patient falsified a consent form to receive a dose of Moderna after previously receiving one dose of Pfizer. Patient was advised to not finish the Pfizer series, but went back to the original site to receive a second dose of Pfizer. He received a total of 3 doses of mRNA vaccines.
Patient received Tdap on Right Arm and experienced extreme muscle pain around the injection site. The forearm began to feel numb. Eventually the pain spread to the armpit and became painful in that region. Pt took Tylenol and the pain has improved. He had to be seen by a urgent care clinic whose providers suggested careful monitoring for the next couple days.
I haven't had menstrual cramps since I have been a teenager. These have been entry month since the shot.; This is a spontaneous report from a contactable consumer. This 46-Year-old female consumer (patient) reported that: A 46-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EN5318), via an unspecified route of administration, administered in left arm as dose 2, single on 13Feb2021 13:00 (at the age of 45-year-old) for COVID-19 immunization at Pharmacy. Patient had no medical history and had no known allergies. Historical vaccine included patient previously took first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection; Lot Number: EL3246), via an unspecified route of administration, administered in left arm as dose 1, single on 14Jan2021 13:45 (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); vitamin D nos (VITAMIN D NOS); vitamin B nos (VITAMIN B NOS) and bupropion hydrochloride (WELLBUTRIN) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received any other medications with Vitamin E, D and B. Wellbutrin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 21Feb2021 14:00, the patient had severe menstrual cramps and didn't have menstrual cramps since she was a teenager. These have been entry month since the shot. No treatment was received for the adverse events. At the time of this report, the outcome of event was unknown.  Follow-Up (23Sep2021): Follow-up attempts are completed. No further information is expected.
severe pain in L suprascapular region and down lef arm to elbow x 1 week. Unrelenting, but worse with movement.  Unable to work.
Thursday evening, after the vaccine, she said she started itching all over her body and developed hives/ increased itching in places that she sweated more. She took scheduled Benadryl the rest of the night and the next day. On Friday, she received a shot of Novocain at the dermatologist's office. Friday night at approximately 9:30 pm, her husband woke her up for the next dose of Benadryl and  saw that her bottom lip was extremely swollen. They went straight to the ER for treatment.
This case was considered medically important. Information regarding PREVNAR was received from a consumer, the grandmother of a 5 month old male patient who experienced pneumococcal pneumonia. The patient possibly received a dose on an unspecified date. On an unspecified date, the patient experienced pneumococcal pneumonia. The patient's outcome was unknown. The reporter stated she did not know if the patient had received PREVNAR vaccinations prior to the event. No additional information was available at the time of this report.
Information has been received from a registered nurse concerning a 15 year old female patient with a history of previous episodes of dizziness and tonic-clonic movements who on 01-MAR-2010 was intramuscularly vaccinated with GARDASIL.  The registered nurse reported that on 01-MAR-2010 the patient experienced dizziness and tonic-clonic movements.  Then the patient continued to feel dizzy, had blurred vision and was send to the emergency room.  The patient blood pressure was measured (results not provided).  The same day, the patient recovered from dizziness, tonic-clonic movements and blurred vision.  Additional information has been requested.
Patient received the covid vaccine on 1/26/2021 Two hrs post injection  c/o pain/soreness at site. Four hrs post injection c/o general body ache, slight headache, fever 99.7.    Denies any respiratory, ocular, or GI symptoms.  Note - injection lot # not available.
MALNOURISHED; NOT ABLE TO EAT; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism, hepatitis c, and liver cirrhosis, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182266, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced sore arm. On 22-MAY-2021, the subject experienced malnourished. On 22-MAY-2021, the subject experienced not able to eat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 21-MAY-2021, and the outcome of malnourished and not able to eat was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Started as a small rash on the arm opposite from injection site on 9/30/19, then progressed to widespread hives on stomach and back and some on arms and legs,  Also developed swollen lips on 10/2/19. No treatment received on 9/30/19 except Benadryl. On 10/2/19 received cortisone injection and oral dose pack and continuing Benadryl.
Appendix ruptured; Possible appendicitis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient of an unspecified age received bnt162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) Dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing (Verbatim: Cholesterol), thyroid disorder from an unknown date and unknown if ongoing (Verbatim: Thyroid). Concomitant medications included levothyroxine for thyroid disorder, start and stop date were not reported; simvastatin for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 10Mar2021 (Lot Number: EN6208) via an unspecified route of administration in the left arm for COVID-19 immunisation. Consumer stated, "I didn't know if you are collecting data on possible appendicitis side effects from the Pfizer vaccines. I started getting sick on 21May2021 and then, went to the doctor on 25May2021, who just told me I had a gastric virus and to take probiotic. I continued to feel bad and the pain got severe with fever on the 29May2021 and I went to the walk-in clinic on 31May2021, and they sent me to the ER and I was admitted to the hospital on 31May2021. Consumer stated reason of hospitalization was "my appendix ruptured." I was released on 03Jun2021." Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.