chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a rash all over my body that would come and go. It was unpleasant but not painful I had extreme fatigue, body and joint aches headaches. It was very similar to when I had Lyme disease. It has recently cleared up. I was unable to work for 3 weeks. My acupuncturist gave me Chinese herbs and acupuncture treatments. That treatment was helpful. My primary care doctor only recommended rest and liquids. For the rash, she recommended Benadryl. This lasted until the end of May/beginning of June, about 3 months.
Vaccine on Monday 4/5, Stroke like symptoms on 4/7 headache, confusion, couldn't find her words, fatigue. ED visit early 4/8 determined TIA and ASD
This spontaneous case, initially received on 16-Oct-2018, from other health professional (pharmacist) via pharmaceutical manufacturer (Merck). Concerns an elderly, male patient of unspecified age. On an unspecified date, the patient was administered FLUAD (TIV) (dose, route of administration, batch number and expiry date: not reported). The patient was also administered PNEUMOVAX 23 (dose: 1, frequency: once, batch number: N032092, expiry date: 12-Dec-2019 and anatomical location: not reported). On an unspecified day after vaccination, the patient experienced redness and swelling at injection site that went from shoulder to elbow, the skin at the injection site was painful to touch. It was reported that, the patient felt flu like symptoms under the weather. At the time of the report, the patient had recovered from the events (persisted for 3 to 4 days). The reporter assessed the case as non-serious.
Information regarding Prevnar was received from a healthcare professional regarding a 3-year-old male patient who experienced sinus infection and had no titers in blood levels. The patient received a dose on an unspecified date. On an unspecified date, the patient experienced a sinus infection and no titers on blood levels. The patient outcome is unknown. No additional information was available at the time of this report.
Local redness infection. KEFLEX 500mg BID x 10d and BENADRYL.
Sensitive skin all over Heat  soreness at site Slight light headed ness Muscle aches Sleeplessness
fever of 102 ax;myalgias;malaise;soreness @ inj site w/o swelling;resolved by 15AUG98;
Incident occured 1/2/09 mid-morning.  Zostavax was situated in the freezer next to Varivax and unfortunately I mistakenly grabbed Zostavax instead of Varivax.  0.5mL IM Zostavax given in left thigh.  When incident was realized parents were called by Dr. explaining what had happened.  Pts mom reported that pt was "just fine."  Dr. informed mother of possible signs and symptoms to watch for.  Mother stated understanding.
BODY ACHE-MOSTLY ALONG THE NECK  AND BACK; STIFFNESS ALONG SPINE; HEADACHE; FEVER (103F); This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid removal, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache-mostly along the neck and back. On 08-APR-2021, the subject experienced stiffness along spine. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache-mostly along the neck and back, stiffness along spine, and headache on 11-APR-2021, and fever on 09-APR-2021. This report was non-serious.
2 days after vaccine I was diagnosed with COVID-19 and treated at an ER facility and sent home with antibiotics. I went back to the ER 2 days later and received more antibiotics. They put me in the hospital and diagnosed me with COVID-19 Pneumonia and I spent a month there. I went into the hospital several times for 3-5 days at a time before that, but on 02/14/22 I was there for a month. One trip they diagnosed me with COVID-19 pneumonia, another trip I was septic, and another one I was diagnosed with COVID-19 pneumonia again. I don't know a timeline but I know it was 2 days after the vaccine. I had shortness of breath, my o2 stats dropped into the 90's and one trip to the ER they dropped to the 70's and I was sent home with oxygen. One of the trips to the hospital they didn't have a correct diagnosis to discharge me home with oxygen. I also had tightness in chest, a cough that felt like I broke a rip, but no fever, not even a low grade temperature. I had been admitted at another HCF before that for 3-5 days before the 02/14/22 hospitalization. I'm still getting my strength back but I am somewhat recovered.
Headache, sore arm, injection site pain, low grade fever (100 F), fatigue, nausea
suffering from extensive skin rash,very itchy' mostly upper body and arms, even scalp.  Very irritating. Have consulted doctor and also dermatologist. Treating with special skin creams which are not satisfactory
Drug ineffective; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ex-31 week preemies" (unspecified if ongoing), notes: ex-31 week preemies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 17Aug2022, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 17Aug2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) positive. Clinical information: Physician stated that as she has 10-year-old twin boys who are ex-31 week preemies. They have vaccinated their family as soon as  vaccine was available. They developed COVID for first time on 15Aug2022 and now twins tested positive on 17Aug2022.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202200046249 same reporter/vaccine/AE, different patient;
positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer sponsored program, IBCC (Inbound Call Center for HCPs) via a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EKS730), via an unspecified route of administration in deltoid left on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient received the first dose of the vaccine on 22Dec2020 and a week later she was tested positive for COVID on 29Dec2020. She was due for the second dose the day before the time of the report. She was concerned about the immune system before getting the second dose. She got a significant pneumonia on 29Dec2020 with COVID infection that her coworkers did not get and she was worried about the condition of her lungs and getting the second dose of the vaccine. She had done her research and read what the CDC said about waiting longer for the second dose. Patient had a fever on 26Dec2020, 4 days after getting the vaccine, she was scheduled to get the second dose on 12Jan2021, but she did not go in, since she couldn't get straight answers from anyone about the second dose, her question was: when could she get the second dose?  Patient was feeling better, she didn't get a repeat chest X-ray, but she felt, like she didn't have fevers, she felt like much better. Her fevers started 4 days after the vaccine on 26Dec2020, and lasted 5 days, maybe 2 days into the antibiotics it stopped. She had recovered completely from fevers. Stated her first test, she tested negative, on 27Dec2020, then tested positive on 29Dec2020. She had no test since then, since one could shed the virus for months, and she didn't feel the need to retest, she was past the point on quarantine. Lab data included Chest X-ray: Pneumonia on 29Dec2020, COVID 19: Negative on 27Dec2020, COVID 19: Positive on 29Dec2020. Outcome of event fever was resolved, and of other events was unknown. Causality: She couldn't say for sure no, but she questioned if put her in a more vulnerable state.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive for Covid" and pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PT SAID HE STARTED HAVING GI SYMPTOMS INCLUDING DIARRHEA, VOMITING, BLOODY STOOL AROUND TWO MONTHS AFTER VACCINATION. HE WAS ADMITTED TO THE HOSPITAL AND STAYED FOR FOUR DAYS WITH ULCERATIVE COLITIS.
Mother reports pt. had mild rash to (R) arm evening of shot and "itching". By next night (R) torso also covered in rash and pt. reports "itching".
INJECTION SITE/ARM HAS RASH, REDNESS, PAIN AND WARM TO TOUCH. TREATED WITH IBUPROFEN AND BENADRYL.
A report has been received from a Health Professional concerning a patient, Female subject who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST started on an unknown date. The patient experienced ADMINISTERED EXPIRED FLUMIST. The outcome of the event of ADMINISTERED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
After 1st shot (administered 6/28) ~7/10  severe pain in right mid back, thought it was kidney stones went to ER got mri and nothing and told most likely side effect .  After 2nd shot (administered 7/21)  on 8/7 severe pain in upper right back.
right deltoid 6cm x 6cm erythemous warm and tender.  pain level at 5, on a scale of 10, afebrile, onset evening of 11/18/2004, and pain through the night.
redness at the injection site; a rash at the injection site came back with redness and continued to get bigger; general fatigue; Fever; a little red lump arises at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (a little red lump arises at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger), FATIGUE (general fatigue) and PYREXIA (Fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.   The patient's past medical history included No adverse effect (No Medical History Provided).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced INJECTION SITE MASS (a little red lump arises at the injection site), FATIGUE (general fatigue) and PYREXIA (Fever). On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger). On 31-Dec-2020, INJECTION SITE MASS (a little red lump arises at the injection site), FATIGUE (general fatigue) and PYREXIA (Fever) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (a rash at the injection site came back with redness and continued to get bigger) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Company Comment  Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Injection. The events of injection site mass, injection site redness, injection site rash, fatigue,and fever are consistent with symptoms of COVID-19. hence also assessed as unrelated to mRNA-1273 use.
Headache, Myalgia, CHILLS, VOICE-CHANGE Narrative:
p/vax deep, aching pain in upper arm lasted for 2-3 weeks;pain still but hurts only when lift, stretch, pull arm as of 8/2/99 still bothers pt;
rash almost all the body except for the bottom part of the leg; rash and it wasn't just in the injection site; feels warm to the touch; all over her arms, trunk, torso area and also on her thighs, it was like bumps that turned into like a sunburn almost; allergic reaction; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8732 and expiration date: 31Jul2021), via an unspecified route of administration, administered in Arm Left bicep on 24Mar2021 18:45 (at the age of 28-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took ceclor and had a reaction to drug. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. The patient started experiencing an adverse reaction on 29Mar2021. The patient developed a rash, and it wasn't just in the injection site, almost all the body except for the bottom part of the leg that was considered normal or severe. It was kind of all over her arms, trunk, torso area and also on her thighs but it was like bumps that turned into like a sunburn almost. It was reported that, it had cleared up now and was like a sunburn like it had just changed the color of skin to just reddish and feels warm to touch. At the time of report, it was clearing up and she confirms it was ongoing but improved, it had improved a lot as it was almost gone. The patient wanted to know if she should get second dose of the vaccine after experiencing the rash. The patient went to emergency room due to the events. No relevant tests were done. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
past 2nd dose time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past 2nd dose time) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past 2nd dose time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past 2nd dose time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.
7x20 cm area of erythema and induration at and distal to site of vaccination.
mom reported on 31AUG93 to ctr that w/prev vax pt broke out the following w/red whelps all over body; these red areas lasted 4 days; no medical attention was sought;
p/vax pt awakened w/T101; awakened following day w/red macular; papular rash on buttock; abdomen; legs & face; rash resolving
Erythematous papules over arms, legs, and upper chest. Some areas of urticaria over elbows. Gave BENADRYL 12.5 mg BID and ranitidine 150mg bid.
79 yo with HFpEF, CKD, neurogenic bladder with chronic indwelling Foley admitted to Facility 01/21/21-01/28/21 with recurrent c. difficile/sepsis.  Received COVID vaccine on 2/3/21 as outpatietn.  Readmitted to Facility on 02/16/21 with sepsis with E. coli BSI from GU source, recurrent/persistent c. difficile colitis.  Worsening sepsis.  Family transitioned goals from full code to DNR/DNI and then to CMO.  Patient expired 02/18/2021.
SEVERE INDIGESTION/ESPHAGEAL SPAPMS,LOW GRADE FEVER,SWEATING,FATIQUE,MILD HEADACHE,NAUSEA. RESOLVING AFTER TWO DAYS. NO TREATMENT
pt vomited w/in 15mins following vax, had rectal temp of 100.9
1 week and half after covid booster, developed red streak on R upper arm and palpable lymph node. Booster was given in L arm.
Vaccine into shoulder joint causing pain, limited range of motion unresolved over a month. Prednisone injection and physical therapy. Limited range of motion, aching, and nocturnal pain continues to present (1/4/2019).
7-31-08 at 1146. Patient fainted leaving office; lasting few seconds, pale, dizzy. States didn't eat breakfast.  Alert, awake, answering questions apppopriately. WNL vital signs.
Patient reported swelling of her lips and left eye within 2 hours of administration. She took 25 mg of BENADRYL at that time and repeated the dose two hours later. She never experienced difficulty breathing. She felt better after the 1st dose of BENADRYL, but took a second dose to be safe. No other treatment was required.
Throat swelling; Dizziness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A male patient of unspecified age received the first dose of bnt162b2 (lot number: EL1284), intramuscularly on the left arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and dizziness on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Redness, itching, swelling at injection site. Pt stated numbness in arm that radiated from hand up to jaw on patients left side (injection arm)and also headache.  Pt went to physician and was given a dose of steroid, but she was unsure which one. Symptoms resolved after approximately one week.
Four year old started complaining of not being able to breathe and severe stomach cramps all of this happened about 45 minutes after leaving the clinic. Her face had swollen Eyes swollen shut, mouth swollen it looked like she was beaten.
Patient had a fever of 100.8, vomited three times had a heart rate of 160. was given ibuprofen which brought his temp down for 4 hours. Patient had a temp of 100.6 later in the evening moderately controlled by ibuprofen.
On 3/3/21, I woke up with stomach cramps. I began having diarrhea that day and it continued both night and day until 3/11/21. During that time, I spoke with my Primary Care doctor, who recommended Imodium, Gatorade, bananas, and Yogurt. These  items were what I lived on until it finally ended on 3/11/21. I contacted my Cardiologist, who gave me an appointment for Tuesday 3/16/21. He did not feel that there was anything in the shot that would harm me. Since I went through this with my first shot, I am quite fearful of the second shot scheduled for 3/29/21. None of the websites regarding the COVID shots has mentioned a reaction/side effect of diarrhea. I am concerned that I may be the only one. I hope you can help.
Initial misuse report received from a healthcare professional on 23 May 2013. a 7-month-old patient had received ACTHIB and it was reconstituted with menactra. No adverse event was reported. List of documents held by sender: none.
Started to pee a lot after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Started to pee a lot after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYURIA (Started to pee a lot after the vaccine). At the time of the report, POLYURIA (Started to pee a lot after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No treatment medications were reported
Pt has Moderna Covid shot number one.  Within a  week she started haveing swings in her Blood pressure some times associated with numbness sensation left face, arm and  left lower extremity.   I saw  her on  March 27 with the same.   Neg CT work up, including neg CT angio gram of head and neck.  I transfered pt for insurance reasons.  I called and spoke with  her daughter on April 2.   Pt was having same symptoms, although improved.   I ask about MRI. She was told that there may or may not have been a stroke on that study. .   My impression was CVA with subjective left sided parestesia or TIA.
Same day post vax, the pt reported a rash on arm. Mother called and reported rash had covered back of child, did not itch and was gone in 24 hours. Mother also states child had fever and her legs were extremely sore and aching. Denies any difficulty with breathing.
Severe pain at injection site shortly after given. 2 days later fatigue, malaise. 3 days later (5/14/15) flare of abdominal pain and diarrhea (dx Irritable Bowel Syndrome).
Got shot, now have it/Suspected vaccination failure; Now have it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received Shingles vaccine. In February 2023, between 10 and 11 months 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient got his/her shot in April and now had them. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the primary schedule and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. Vaccination date and onset date was partially captured considering that in April 2022 patient got the vaccine and in February 2023 got the shingles and accordingly time to onset was captured.