chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
chills Narrative: obtained rash and swollen left arm 1-2 weeks after first dose (received 1st dose in left arm); no other symptoms; received Medrol dosepak and it resolved; received second dose in right arm and left arm became swollen again; pt also developed fever and chills, hallucinations (during fever) that have resolved
Patient passed out about a minute after vaccines. He shook some and then came to. Snack was given and monitored for 15 minutes.
Pt received immunizations on 12/14. On 12/22 - fever started. Rash on chest and forehead. Lasted about 3 days. Rash on both sides of thighs. No additional fever. Mom is concerned about rash and scabbing on thighs at the injection site. Mom has been using neosporin on the rash. Rash does not bother child at all.
PT REPORTED CHILLS/FEVER BEGINNING ABOUT 1 AND 1/2 HOURS POST-INJECTION. BY NIGHT PT EXPERIENCED SWEATS, NAUSEA, JOINT PAIN (HANDS, ELBOWS, WRISTS, KNEES). PT TOOK TYLENOL FOR SYMPTOMS. REPORTED RXN APPROXIMATELY NOON TODAY. STILL HAD JOINT PAINS. PT QUESTIONED WHETHER RADIATION THERAPY ONE YEAR EARLIER MAY HAVE CONTRIBUTED, AS HE HAD NEVER EXPERIENCED AN ADVERSE REACTION PREVIOUSLY.
Breakthrough COVID first vaccine 1/14  93 y/o M with pmh of IDDMII, HTN who presents with chest pain x3 days pressure like across the chest not associated with exertion. States the pain is up to 8/10 and has associated dizziness, gen weakness and anorexia. States associated pain in arms and neck with  increased tenderness  States that rest improves it.  came in today d/t progressively worsening pain denies any orthopnea, PND, LE edema Denies any cough fever chills.  Denies any N/V/D denies any similar pain events in the past and never had any cardiac work up or testing
Information has been received from a physician via Pfizer (MFR control# 2016538484) referring to a currently 64 year old female patient. Information about concurrent condition, medical history and concomitant medication was unspecified. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, lot#, expiration date and route unknown) for prophylaxis. On an unknown date the patient had allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and experienced fever. The outcome of the events was unknown. The reporter considered the events were related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The patient also had allergy to varicella virus vaccine live (oka/merck)(manufacturer unknown) (captured in MARRS 1612USA005810). Additional information has been requested. Sender's Comments:  US-009507513-1612USA005810.
It was reported that a 45 year old female received TD ADS Adult vaccine on 6/20/99 and reportedly, on 6/27/99, she experienced a large local reaction at the injection site that appears to be getting larger.
Edema, induration and vesicles to right deltoid.  Treatment with Benadryl 1 to 1 1/2 tsp PO PRN itching.  warm compresses to be applied to the area TID.
The patient experienced soft tissue pain and limited range of motion in the right shoulder after a reported COVID vaccination. Information is limited as the vaccine was performed at the Facility. His exam was most consistent with adhesive capsulitis.
pt recv vax 19OCT96 & 20DEC96 started having diarrhea, vomiting, fever, chills, & heartburn for 4 days;pt saw MD & was prescribed heartburn med;pt recovered;
Was given a second dose of Janssen.  He answered no to the question of if he has ever had a covid 19 vaccine.
Mom reports red, firm swelling to left deltoid area when DTaP given about the diameter of baseball. She noticed at 5/29/02 early afternoon, no fever, gave Motrin and ice pack to site. Area looks better today 5/30/02 still some swelling, warmness and redness to arm. Pt doing well. Told mom to continue cold pack and Tylenol for pain.
VOMITING; SEVERE FEVER; MYALGIA; This solicited report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient's initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient's experienced vomiting, severe fever, and myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe fever, vomiting and myalgia was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and vomiting, severe fever, and myalgia as related. Company causality between covid-19 vaccine ad26.cov2.s, and vomiting was not related and related for severe fever and myalgia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210666118-COVID-19 VACCINE AD26.COV2.S- vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210666118-COVID-19 VACCINE AD26.COV2.S-severe fever, and myalgia. This event(s) is labeled and is therefore considered potentially related.
*Redness, inflammation, pain, and burning feeling at injection site. Inflammation subsided within 48 hours after injection. Redness, pain, and burning feeling subsided within 72 hours. *Headache, full body muscle aches, and stiff joints developed 3 hours after injection. I took ibuprofen, which had no effect. Headache, body aches, and stiffness subsided within 24 hours. *Fever of 100.4 F developed 3 hours after injection. My normal temp is 97.9 F. I took acetaminophen 6 hours after developing the fever, which resolved about 8 hours later. (The fever is the primary reason I'm submitting this report. I have not had a fever in more than 45 years, so this symptom stood out.)
a low grade fever (99F-100F); slight headache; "cold symptoms"; coughing; sneezing; blowing her nose; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. About a week later, she reported a low grade fever (99F-100F) along with a slight headache and "cold symptoms" including: coughing, sneezing, and blowing her nose. She went for a rapid covid test 9 days after vaccination, which was positive, and she's waiting on an additional covid test that was sent to the lab. The outcome of events was unknown.
Immediately after the vaccine, mild increase in temperature (Childrens Tylenol was given to bring it down).  Later that night and since, child was grunting, throwing self into spinal extension, sleeping habits broken with bouts of unusual screaming and fussiness.  Still ongoing.
Patient is having tightness he says start with the fist dose of SHINGRIX. His arm can only be lift to his shoulder.
Pt received vaccine in R arm at approx. 3:45 PM and was advised to wait in observation area for 30 minutes due to patient history of having multiple allergies. At approx. 4:15 PM pt alerted observation RN of a single isolated raised bump on R arm located approximately 4 inches away from vaccination site. Raised bump is noted to be 0.5 square inches large with surrounding redness. Pt denies any itchy, irritation, to the bump and otherwise reports no symptoms. Pt advised to stay in observation for an additional 15 minutes. 3 RN skin check of his chest, back, and abdomen revealed no other bumps or redness of any kind. Pt discharged at 4:35 in his mother's care. Pt and pt's mother advised to go to urgent care/emergency room in the event that any further reactions occur while at home.
Shingles on left side of face under eye down to lip. Swelling. Severe headaches, fatigue and weight loss. shingles has subsided but all other symptoms are still there.
3 episodes of epistaxis over 2-3 weeks - two after getting upset, one totally unprovoked
Loss of consciousness. Examined patient and monitored until stable. Discharged in care of father.
Fever and rapid heart rate.  Went to ER and had blood tests and EKG and IV fluids.  Heart rate was up in the 160's and came down to the 120's.  This was about 15 hours after the vaccine was administered.  He has never had any symptoms like this before. Saw a cardiologist on 9/2. His heart rate had gone down to 107 and he still had a fever.
This spontaneous report as received from a physician refers to an 81 year old male patient. Within in the last six months, approximately in November 2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). Within two weeks, approximately on 26-APR-2013 the patient experienced shingles. The patient also developed and was still experienced post herpetic neuralgia(PHN). The outcome of adverse events was reported as not recovered. The patient had sought medical attention via office visit. Additional information is not expected.
Bleeding, bruising  Platelet Count dropped to 2  Immediate Platelet Transfusion Prednisone and Promacta   Receiving Treatment for ITP Diagnosis
Shot 3 PM on the 9th felt ill 8:30-10:00 AM the next day during that time (8:50) fainted out for only a short time for 5 days- muscle soreness in the arm at the site of the shot.
Patient was given the adult dose of  0.5ml of flu vaccine instead of the pediatric dose of 0.25.
On 2/13/2007, our son, age 2 months received the oral vaccine Rotateq at his routine 2 month well-baby check up. Two days later he developed diarrhea which lasted 7 days. During this period he became very fussy during feedings and lost his appetite. On the seventh day of his diarrhea, he was switched form his regular mild-based formula to soy formula. The diarrhea ceased, however the feeding issues remained. The feeding resistance he was exhibiting turned to overall feeding refusal, insomuch that he needed to be fed asleep, on in a very near sleep stage. He also developed a cough and wheezing. Labs were drawn weeks later and have been repeated several times since. The results all show elevated liver enzymes and acidosis. It is our belief that the Rotateq vaccine is responsible for  the problems my son is experiencing, and we have asked the Dr to report this incidence to manufacturer and VAERS in order to initiate a formal inquiry on our behalf.
Erythema, swelling, aching pain, chills, sweating, limited range of motion of left upper arm, lasting 3 days at time of evaluation at urgent care. Review of medical record shows patient had previous pneumonia vaccine in 1/26/15, and now again on 3/23/16.
This spontaneous report received from a pharmacist referred to a 71 year old female patient. The patient's medical history, concurrent conditions were not reported. Historical drug included PREVNAR 13 which taken on an unknown date in 2015. On 21-OCT-2016, the patient was vaccinated with influenza virus vaccine inactivated (unspecified) (FLU SHOT) and in the opposite arm the patient was vaccinated with PNEUMOVAX 23 (lot number: L027732, expiry date: 23-FEB-2017) (dose and route were not reported). The patient's arm that received PNEUMOVAX 23 had redness and swelling that extended to her back and a bruise under her arm that began 1 or 2 days after the injection that worsened after 3 to 4 days. The redness continued and was present a week ago. The patient also experienced pimples on her abdomen and the front of her legs that began on an unspecified date that improved with BENADRYL taken on unspecified dates. The patient went to an unspecified urgent care center on 23-OCT-2016. The event pimples was resolving. It was unknown of her present status or if she had recovered from the other events. Causality assessment was not resolving. It was unknown of her present status or if she had recovered from the other events. Causality assessment was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
24JUN96 PM-screaming unconsolably, vomited x1, fussy up & down until 4AM 25JUN96;now better
The pt received the vax and developed a raised, erythematous area that covered a 5 x 5 cm area.
Debilitating nausea for three days following injection, chronic indigestion and acid reflux over the course of the following month. No treatment yet given.
Information has been received from a licensed practical nurse referring to a patient of unkown age and gender. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot#, exp date, dose and route were not reported). No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
pt recv 2nd dose of vax 2NOV95 & did not seroconvert p/this dose;
Arm pain; Arm Swelling; Armpit swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025O21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient stated that those symptoms are very painful. Symptoms are ongoing after a week.  No concomitant products were reported
vax and get shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, seen plenty of people get the shingles vaccine and still got a terrible outbreak of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR201252 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201252:same reporter
Acute idiopathic maculopathy; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: MACULOPATHY (medically significant), 7 days after the suspect product(s) administration, outcome "unknown", described as "Acute idiopathic maculopathy". The patient underwent the following laboratory tests and procedures: Angiogram retina: showed focal staining in the late stage and, notes: diffuse pooling within the serous detachment.; Sender's Comments: This is a Literature report. Based on the currently available information, a reasonable possibility that the reported adverse event maculopathy is associated to the administration of the suspect drug COVID- 19 vaccine cannot be completely excluded in this patient.  Noteworthy, age and patient medical history are key factors to fully elucidate this report.
FAMILY MEMBER REPORTED VIA PHONE PATIENT NOT FEELING WELL AND WILL BE TAKEN TO URGENT CARE
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as unk, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient had no Known allergies. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) positive; (09Jul2022) negative; (16Jul2022) positiive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient tested positive on 04Jul2022, started Paxlovid from 04Jul2022 evening to 09Jul2022 morning. Then tested negative from 09Jul2022 to 13Jul2022. But I started covid symptom again and tested positive again from 16Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
This spontaneous report as received from a IR Administrator of the clinic, and refers to a 12 months old infant patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 09-MAY-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L048468 (strength, dosing details, anatomical location were unknown). All the VARIVAX vaccines with lot # L048468, were moved to the backup freezer on 15-APR-2016 and moved back at the end of AUG-2016. This is one of the several reports reported by the same reporter. Additional information has been requested.
This study case was received from the investigator in the trial on 19 August 2011. A 21-year-old male subject received on 29 April 2011 received the following vaccination: an injection of a ACAM2000 (lot number not reported). On 20 April 2011, the subject received the following vaccinations: Hepatitis A and Hepatitis B vaccines (manufacturer and lot number not reported) and TYPHIM VI (sanofi pasteur SA lot not reported). The subject has no significant medical history. The subject's electrocardiogram (ECG) on 09 May 2011 was abnormal. On 10 May 2011, the subject had an abnormal troponin I of 00.4 and a normal echocardiogram. On 09 May 2011, the subject was diagnosed with other and unspecified acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
From Midnight on 3/28 - Low grade fever (up to 103.1), chills, extreme headache, nausea, aches, cold sweats, dizziness, extreme fatigue through Sunday, 3/29 mid-morning. Sunday, 3/28-headache, nausea, dizziness, extreme fatigue and cold sweats Monday, 3/29-nausea, dizziness, extreme fatigue and cold sweats Tuesday, 3/30-dizziness, extreme fatigue, loss of appetite Wednesday, 3/31-fatigue, loss of appetite Thursday, 4/1-loss of appetite
Within 2 to 3 hrs after vaccination, the pt started running a fever, swelling at site and rash that went all over body with some itching. Tried Benadryl and Calomin lotion with no relief-presented to MD on 04/04/2002. Reaction to vaccine. Treated pt with medrol dose pack, adarax.
Case number PHEH2015US026832, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
This spontaneous reprot as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.