chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 10:00 as dose 1, single (Lot number: EL9262), in right arm, on 19Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm and on 29Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FE3590) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 21:00, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19. Treatment start date: 12Jul2022 and stop date: 15Jul2022. Lot number: FX8140. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201025685 Same patient, different product and event;
Extremity numbness, subjective leg weakness, hyperventilation, anxiety; onset approximately 3hrs after vaccine; self resolved over next 2 hours.
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 08-MAY-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
A county inadvertently gave a 16 year old for the first dose of Moderna; A spontaneous report was received from a HCP concerning a 16 Years-old patient of unknown gender who experienced  the first dose of Moderna given by a county inadvertently.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  A county inadvertently gave a 16 year old for the first dose of Moderna. Treatment details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event- inappropriate age at vaccine administration was unknown.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no reported AEs.
painful red rt knee, low grade fever, tender, WC 27,000 adm dx r/o septic arthritis;In the hosp swelling subsides, fever dec & repeat WC 18,000;dx  rt thigh swelling secondary to immun
This spontaneous report has been received from a pharmacists concerning a patient of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date in 2009 patient was vaccinated with ZOSTAVAX (strength, dose were not reported). On 24-SEP-2015 the patient was vaccinated with second dose of ZOSTAVAX lot # L011536 with an expiry of 03-JUL-2016, 0.65 ml, subcutaneous. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pt experienced a screaming fit after his first DTaP for more than 3 hours.
rash-hives, diff breathing approx 2hr p/vax;tx w/DPH;
Prevnar 20 was already administered in December 2022; Additional dose not indicated; Pt reported diarrhea x 2 days, also reported right side pain 3 days following immunization- shot was administered in left arm.
Post vaccine became dizzy, fainted. Brief LOC Ginger ale/crackers given. No loss of urinary/bowel function. Per front office staff student's upper and lower ext became rigid.
arm sore 10days p/vax,devel t104,pain behind eyes,fatigue,lethargy, dark urine. 19SEP94-f/u-hepatitis of unk etiology, consistent w/late convalescence recovered fr HEP B.
It started with nasal congestion, sore throat and then followed with dry cough. I also had fatigue. It started Sunday and I did the at home test on Tuesday and tested positive for COVID-19. I called my PCP and we had a virtual appointment. I reported that my blood oxygen level was normal. I was advised by the doctor and prescribed PAXLOVID. As of today, my nasal congestion and sore throat have gone away. Cough has gone away. My voice is lower than normal and I still have fatigue.
lesions at the back of her hand; rash on both elbows/ rash on both hands; itchy nodules on both elbows; tiredness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (itchy nodules on both elbows), SKIN LESION (lesions at the back of her hand), PAIN IN EXTREMITY (sore arm), RASH (rash on both elbows/ rash on both hands) and FATIGUE (tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). On 01-Feb-2021, the patient experienced NODULE (itchy nodules on both elbows) and RASH (rash on both elbows/ rash on both hands). On 02-Feb-2021, the patient experienced SKIN LESION (lesions at the back of her hand). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown, FATIGUE (tiredness) had resolved. At the time of the report, NODULE (itchy nodules on both elbows), SKIN LESION (lesions at the back of her hand) and RASH (rash on both elbows/ rash on both hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-254039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document was received. Reporter's contact information was updated. New event rash was included. It contains significant information.
A 13 year old male pt experienced limb pain and numbness, weakness, agitation, faintness, headache, stomach ache and fever after receiving RabAvert therapy. The pt received four doses of RabAvert (lot 323011, expiration date Apr06), the first on 20Nov03, second on 24Nov03, third on 28Nov03 and the fourth on 05Dec03. On 20Nov03 after his first dose of RabAvert in the left gluteus, he experienced left arm pain and numbness which resolved prior to leaving the physician office. On 24Nov03 he received his second RabAvert dose in the deltoid and BayGam around the site of the wound and the rest in the right gluteus. The pt was to received BayRab but BayGam was administered instead. On 25Nov03 he felt rather bad with weakness, sort of hyper, kind of faint feeling, headache and stomach ache. Fever developed in the evening and he did not feel well. He required no treatment medications or medical intervention and was fully recovered on 26Nov03. On 28Nov03 he received his third RabAvert dose and BayRab. That day he experienced agitation which was resolved by the next morning. Follow up received 30Dec03 and 02Jan04: Additional information provided by the physicians office. Site of wound: finger. The fifth dose of RabAvert given 19Dec03 with no adverse reactions. All RabAvert doses were 1ml, administered IM. On 11Dec03 the Rabies Antibody titer: 5.17 (norm: >or=0.50 post vaccine). The pt has recovered completely.
pt recv vax 22AUG94 & on 25AUG94 pt exp urticaria & petechiae on the abd & back; MD reported that the pts sx were attributed to Henoch-Schonlein purpura & were not related to vax;
Loss of balance, falls, cognitive  changes, started falling April 2021 2-3 times, may falls 2-3 times, change  in facial expression. Fell 5/13/21 hit toliet, bruised back. 6/03/21 fell at hospital. 7/20/21-fell on sidewalk. hit head + shoulder taken to ER 7/20/21  ER visit - Medical Center 7/20/21 - Labs -> normal - CT of head - normal - Referred to neurology-
Pt had flu shot 9/26/11, nausea, dizzy, ringing in ears, light headed.
2.5 mo. female vaccinated with ROTATEQ-R- vaccine on 8/18/09 under FDA IND #13843. Patient tolerated vaccine. On 8/25/09 follow-up visit, mother related infant had loose, water stools. 8/22 - 1 loose stool, 8/23 and 8/24 - 4 to 5 loose stools. 8/25 and 8/26/09 patient had 2 watery, loose stools. All symptoms resolved on 8/27/09. Patient had normal feedings throughout the duration of symptoms. No other symptoms were noted. This serves as the final report and 15 day report for this adverse event.
Information has been received from a physician concerning her daughter, an 18-year-old female, who in July 2008 was vaccinated with the first dose of GARDASIL 7-10 days after the dose was given, the patient developed asthma like symptoms and sought medical attention and was treated with oral steroids for 3 months. The patient recovered. In October 2008, the patient was vaccinated with the second dose of GARDASIL. 7-10 days after the dose was given, the patient developed asthma like symptoms again and sought medical attention and had to be treated with steroids for 3 months. Subsequently, the patient recovered again. Prior to the vaccinations the patient did not have asthma symptoms for over 10 years. No further information is available.
2/5/2009--Back of L arm--upper area--above elbow and below arm pit swollen.  Approx 70 mm long--warm to touch.  Redness noted at two injection sites  only.  Patient alert and oriented--pt being given Tylenol by mother arm is 8 and 1/2 inches round L.  R arm is 7 and 1/2 inches around--not swollen.  Reviewed s/sx to watch for. 2/13/2009--Spoke with grandma today--L arm is fine now--no more redness, etc.
Patient called into clinic on 7/14/17 at 1024 complaining of right arm pain with 2 quarter size bumps at injection site that are red, hot and hard to the touch. Patient given homecare instructions. On 7/14/17 patient went to local Emergency Department where she was discharged common vaccination response to PNEUMOVAX without evidence for serious complications such as skin infection or abscess formation. She returned to another ED on 7/15/17 where she had a US done that was positive for cellulitis and was given abx. She went back to ED again on 7/16/17 had another US that was WNL no sign of abscess or cellulitis.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. The FDA analysis does not acknowledge the death of this white male, on 5/16/00 from so-called rapid onset ALS. According to the wife, the military never submitted a report on his illness or death.
2inx2in raised area of erythema with tenderness to area. Given Motrin TID, Amoxicillin BID, Elidel cream TID to site.
Information has been received from a company employee who heard of someone who saw a female faint after receiving GARDASIL (lot# not reported). It was reported that apparently the female stood up immediately after receiving the injection and that's apparently when she fainted. At the time of this report, the patient's outcome was unknown. No further information is available.
This case was reported by a lawyer and described the occurrence of neurological deficit in a male subject aged between 10 and 19 years old who was vaccinated with DTP ((A or W not known), manufacturer unspecified), Oral polio vaccine and unspecified vaccine. A physician or other health care professional has not verified this report. The following information was received via legal complaint, which alleged that on or about 15 July 1994, approximately at 6 months of age, the subject received unspecified dose of DTP (A or W not known) (unknown lot number), unspecified dose of Oral polio vaccine (oral, unknown lot number), unspecified dose of Vaccine unspecified (unknown lot number) in a foreign country. On 19 October 1994, the subject was adopted. As a minor, the subject developed normally; he sat up, walked, and babbled at the appropriate ages. He interacted with his parents like a normal infant. The subject's behavior eventually changed dramatically prior to his twentieth birthday, several years after vaccination. He suffered from unspecified neurological deficiencies, cognitive deficiencies and permanent disability. It was believed the subject was exposed to mercury through the mercury-based preservative, Thimerosal, and/or other toxic additives which had been added to several of the vaccine injections that the subject received in July of 1994. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Client received the COVID vaccine (Pfizer dose 1, lot # EW0185, expiration date 5/22/2021) at 2010. The client's father accompanied her, and reported to EMT at 2022 that the client was "hearing echoes." RN, EMT, and another EMT responded at that time. Per the vaccinating RN, the client had stated that she is afraid of vaccinations and has felt dizzy with previous vaccinations, but the client deferred using the zero gravity chair previously. The client's skin was pink, warm, and dry; she was alert and oriented. She denied dizziness, shortness of breath, chest pain, nausea, or any changes in breathing. At 2026, the client's vital signs were as follows: heart rate 66, O2 98, respiratory rate 24, blood pressure 80/50 (using an adult cuff that was too large for the client). The client's pulse was normal. The client stated that "this usually happens with shots" and endorsed feeling anxious. The client was transferred to the zero gravity chair at this time and denied any dizziness with the transfer. The client's father stated that the client has no allergies or medical conditions, and that she takes no medications. The client stated that she ate lunch but no dinner today. The client was offered water to drink at this time. The father of the client deferred taking benadryl at this time. At 2030, the client stated that all her symptoms had resolved. She appeared to be sitting comfortably in the zero gravity chair and continued to drink water. Education provided regarding recommended observation time, activation and emergency management, and primary care follow up. At 2035, the client was able to stand up without any dizziness, denied any return of the "echoes" or ringing in her ears, and ambulated around the room with a steady gait. Vital signs were as follows: blood pressure 82/60 with an adult cuff, respiratory rate 22, pulse 64, O2 99. At 2040, the client reiterated that she felt "back to normal." Both the client and her father denied any further questions. The client ambulated to her car with a steady gait, and was driven home by her father.
Pain, swelling, edema, erythema, warm to site. Treated with Septra DS 10mg take po BID x 10 days.
Patient was given the MMR vaccine in his left deltoid by route of intramuscular but it should have been given by the subcutaneous route. I spoke to the Immunization Program (CDC) and was informed that the vaccination is considered valid and does not need to be repeated. I was informed that the preferred route is subcutaneous but that giving it via intramuscular route will not change the effectiveness of the vaccine. Patient's parent was notified of this error and what the Immunization Program said.
Patient shared she received meningitis vaccine and two hours later she began having shortness of breath, chills, palpitations, nausea, upper abdominal pain, bilateral knee pain and weakness.
Consumer was administered DTP in 1950 & experienced paralysis in lt arm; She associates this incident w/the warning "not to give DTP during a polio outbreak-DTP will activate the polio virus";
feeling bad; Initial information received on 20-Dec-2021 regarding an unsolicited valid serious case received from a patient.  This case involves patient with unknown demographics who was feeling bad while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route for influenza.  On an unknown date the patient was feeling bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was reported," All must killed me after the shot I went down and end up in ICU for 6 days never Ã gain my doctor was looking crazy I felt like I could jump rope until that shot 24 hours after I start feeling bad after that just continue to get worse until my daughter had to call 911"   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (feeling bad). At time of reporting, the outcome was Unknown for the event feeling bad.; Sender's Comments: Sanofi Company Comment dated 24-Dec-2021: This case involves patient with unknown demographics who was feeling bad while receiving vaccine INFLUENZA VACCINE.Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, Based upon the reported information, the role of a vaccine cannot be assessed.
pt stated swelling at injection site.  he did go to his md and was given anti-inflammatory, as of today, states much better and no continuing issues
tingling in vaccine arm grey tinge to hand on vaccine arm fatigue pain across shoulders pain down both sides of spine - Severe pain to adjust head on pillow or shift in bed even the slightest bit felt no need to blink for a few hours slept from 8pm Saturday until 10am Monday - Sleep was the only way to avoid the pain Alleve didn't touch the pain Tylenol began to help after 24 hours low fever around 100.4 skin was super-sensitive to touch swollen lymph nodes in neck on vaccine side swollen lymph nodes under arm on vaccine side - baseball-sized and painful to the touch
Patient was vaccinated on 10/16/2015 about 1:00-2:00pm. Patient started to feel symptoms the moment after the vaccination; the patient mentions like a tingling that went up the upper part of the back. Also had area swollen, red, warm and hardened with pain that extended to the wrist. Patient was went to doctor and antibiotics were prescribed.
Cellulitis skin rash infection about six inches long and 3 inches wide began at the shot site within 12 hours. Very red, raised and firm bump under skin and hot to touch. It started about 12 hours after shot was given. Worsened and spread over the next 24 hours. Continued to worsen.  Contacted my doctor and he evaluated it via telehealth appointment. Docto determined it was skin infection beginning at the site of shot. Augmentin given. Rash began to improve after 2 doses of medicine. After 24 hours of augmentin rash is about 50% improved.  Other side effects were minor and expected. Like headache chills body aches fatigue.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced nausea, pain in arm, exhaustion, feeling unwell and influenza like illness. On an unknown date, the outcome of the nausea, pain in arm, exhaustion, feeling unwell and influenza like illness were unknown. It was unknown if the reporter considered the nausea, pain in arm, exhaustion, feeling unwell and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient would be 51 years old in August 2018. The patient had a SHINGRIX vaccine and assumed her arm would hurt and it did in a big way, but the nausea was ridiculous, she was exhausted, felt sick, almost like the flu and it was horrible. The patient asked that how long did this event would usually last.  At the reporting time, the patient was at the work and was barely making it. She asked if the 2nd vaccine (booster) would be as bad as this. This was horrible and terrible. The patient was embarrassed that she might have to tell her boss that she had to go home due to a vaccine, which was terrible.
4 minutes after COVID vaccine: Tongue tingly then tongue and lips swelled up by 9 minutes. Did not progress til after 30 minute monitoring. On 10 minute ride home the roof of my mouth felt pressure then tingling in throat began. after arrived home throat felt like it was closing so I immediately took the Epi-Pen. Shortly after the Epi Pen the symptoms subsided.
I woke up the morning of the 25th, with some lower abdomen cramping and and low back pain - lasted a few hours - and I was having contractions. I was not dilatated and labor had not progressed past early contractions. Gave me a IV of fluid - Liter; monitored babies heartbeat; They sent me home with antibiotics - for kidney or bladder infections - something along those lines that was irritating my uterus. It subsided (AE) that afternoon - I did 7 days of Macrobid.  Pregnancy history - first pregnancy; Estimated date of delivery: June 10, 2021.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient had not eaten anything all day
heartrate at over 100; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 , single, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 21May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "heartrate at over 100". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient heartrate at over 100 resting for a few hours slowly coming back to normal overnight after second dose. No received other vaccine in 4 weeks. Patient had not covid-19 prior vaccination and post vaccination not tested covid-19. On 19Dec2021, patient received Pfizer covid-19 booster at 12pm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.