chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented approximately 5:40pm on 8/12/21 with her right eye swollen and puffy.  Patient received Moderna COVID-19 vaccine at approximately 3:30pm 8/12/21.  She indicated that this is the response when she is exposed to dust or mold and she has had this same reaction when that happens.
Vomiting; Diarrhea; Headache; Sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ6742) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepiness". No follow-up attempts are possible. No further information is expected.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 with a home test on 08/02/2022. I contacted my doctor via the patient portal for the PAXLOVID vaccine due to my age. I started to fill better after taking the PAXLOVID. As of today, I'm feeling tired but I do feel better.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 87.10 .  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, total doses given for the day was unknown, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.    The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
TIRED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 10-APR-2021. This report was non-serious.
did not feel like herself; fever; shaking; chills; tiredness; arm swelling; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 17 patients. This is the first of seventeen reports. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on 07Jan2021, single for COVID-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient reported that after getting the vaccine she experienced a fever up to 102, chills and shaking on Jan2021. She also reported that multiple friends had the "regular side effects" of soreness in the arm. Patient stated that she got her COVID vaccine shot on along with 15 of her friends. They all had the typical arm swelling, headache, and tiredness if anything. Some did not have any side effects at all. She herself woke up with a 101 fever, then at 11 AM had a 102 fever and was shaking like crazy she could not even hold the thermometer in her mouth on 07Jan2021. On 08Jan2021, (Friday), she began to feel a little better. She just did not feel like herself on 09Jan2021. She got a COVID swab and was negative. After she got the fever she decided to have her blood drawn, and it showed antibodies. Patient was inquiring, because she previously had COVID, is that why she had this reaction. Outcome of the event swas unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021021735 same reporter/ drug/ events, different patient;PFIZER INC-2021026894 same reporter/drug/event, different patient;PFIZER INC-2021026885 same reporter/drug/event, different patient PFIZER INC-2021026883 same reporter/drug/AE, different patient PFIZER INC-2021026893 same reporter/drug/similar event, different patient;PFIZER INC-2021026888 Same reporter/drug/event, different patient;PFIZER INC-2021026890 same reporter/drug/event, different patient;PFIZER INC-2021026886 same reporter/product, diff AE/patients;PFIZER INC-2021026413 same reporter/drug/event, different patient;PFIZER INC-2021026881 same reporter/drug/event, different patient;PFIZER INC-2021026882 same reporter/drug/event, different patient;PFIZER INC-2021026884 same reporter/drug/event, different patient;PFIZER INC-2021026889 same reporter/drug/event, different patient;PFIZER INC-2021026891 same reporter/drug/event, different patient;-PFIZER INC-2021026892 same reporter/drug/event, different patient
Apparent allergic rxn - severe swelling and redness on arm under vaccination site and down to mid lower arm.
On March 9th  walnut sized lumps on  BOTH arms by vain where blood is drawn  in elbow tracking up both arms   Still present on March 12
Unable to lift arm and soreness.  Flu like symptoms - muscle aches, chills, headache
After 1st shot he was paralyzed from waist down; He felt like he lost a good chunk of his life, got screwed; This spontaneous case was reported by a consumer and describes the occurrence of PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAPLEGIA (After 1st shot he was paralyzed from waist down) (seriousness criterion medically significant) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) (seriousness criterion medically significant). At the time of the report, PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  It was noted that the patient lives in a assisted living facility. After the onset of events, the patient reported that he was put in a wheel chair but no longer needs the wheel chair. The patient was also advised by his doctor's not to receive the second shot.   Further information regarding treatment was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Pt received shingles vax in 2010 but got shingles around the first of this year.
No adverse effects reported; Patient received PROQUAD which was administered eith expired diluent MRK; Product preparation issue; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 07-JUN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R015742, expiration date 02-DEC-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis, which was administered with an expired dose of sterile diluent(MERCK STERILE DILUENT), lot#L028663, expiration date 29-MAR-2018. No adverse effects were reported.
This spontaneous report was received from a physician refers to herself as a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 and dose 2 of GARDASIL (dose, route and frequency were not reported). The physician reported that he had received first two doses of GARDASIL and however, she just found that she was 8 weeks pregnant. The physician was asking whether she has to restart the series after the pregnancy. No further information was provided. Additional information has been requested.
She received influenza  vaccine 10/1/10 at around 1000/AM. 10/5/10 notified us at appt the she had had a reaction - 10/1/10 started at 9pm with red, swollen, warm area size of quarter then radiated down upper (R) arm about 1"-2". She then developed chills/aches all over/weakness and here is list of temp 1100/PM - 100.0 degrees, 102.1, 102.6, 103.4, 103.8, 102.9 330/AM 100.5  - She took TYLENOL  alt with ASA and fever finally came down. 504AM 99.9 - 97.6.
skin redness & hives w/gen body itching beginning 25OCT97 cont until 27OCT(7 AM; p/1st dose of DPH occasional itching w/few red spots @ waist remain;
L leg. Child started with red area the night of vaccine given then got blister, red and raised, as went through the weekend. We saw the pt in the office on Monday Feb 22 the area measure 4 1/2 in x 5 1/2 in. Treatment started cephalexin 250/5 TID x 10 days and BENADRYL. Follow up in office on Friday.
COVID ARM-  Delayed reaction to vaccine.  Developed itching, tenderness and soreness, raised red area on the surface of the skin in the upper muscle of the left arm.  Appeared suddenly.  It has only been 24 hours so based on my reading this could last a couple more days.  While I had general soreness  in arm for 24 hours when the vaccine was administered, this is a different response.
Initial health care professional report received on 27 May 2010: This patient received MENVEO (batch number 091001 (liquid component batch number)) unknown dose intramuscularly on 26 May 2010. It was reported that the patient inadvertently received only the liquid component of MENVEO. The outcome of the event was not reported. The causality was not reported.
Left deltoid area red, warm, and swollen at site approximately 6cmx8cm.
it was rpt fr MD concerning pt who was vax & 7-8 days following pt devel a few vesicular lesions.
Right arm-4inx1in rash and swollen around injection site, pain to touch at injection site, feel warm around injection site, feel a lump at injection site. Per patient reported.
2 1/2 hours post vaccine, the patient experienced a headache with blurred vision which lasted until the next day. 4 hours post vaccine, the patient's finger tips became numb and 5 minutes later the patient's tongue became numb. This lasted for about 15 minutes.
At 7:00 pm 48 hours after shots child broke out in rash covering entire body. Rash continued to spread. A visit to the Pediatrician determined the most likely cause was the vaccines. No other symptoms were present.
Patient received Tdap.  Approximately 5-8 minutes after receiving the vaccine, patient told mother she could not see or hear and she was dizzy.  She became limp and mother lowered patient to the floor.  Patient was pale, clammy and sweaty. Pupils were fixed and dilated.  She was slow to respond.  BP: 104/80, R: 24-28, P: 120-130.  Patient fully recovered within 30 min.
Yellow/Green painless bruises about 1-2 inches in diameter. Around the body 6-10.
he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose). At the time of the report, LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company Comment: This case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Liver disorder on unspecified days after receiving the second dose of mRNA-1273 vaccine. Its reported that patient is not the only one with this issues of liver discomfort that he have family members, and people in his socials networks that had the same issue after the second dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Liver disorder on unspecified days after receiving the second dose of mRNA-1273 vaccine. Its reported that patient is not the only one with this issues of liver discomfort that he have family members, and people in his socials networks that had the same issue after the second dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 9/11/01, call to MD office from ER. Child being seen for possible seizure activity. The pt had DTAP #4, IPV #3 and Hep-B #1 on 9/9/01. The child shook all over, was pale and tired. No fever.
Pt received a flu shot on 9/20/10. She came to the pharmacy on 10/04/10 and said she hasn't been able to lift her left arm up since that day. She has no numbness or pain. She can move her fingers and bend her forearm at the elbow.
4/5/2021 - 4/6/2021 admitted for lower GI bleed requiring blood transfusion and hospitalization
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 87 years old patient who experienced an expired dose of FLUZONE HIGH DOSE lot UI892AB, 06-Jun-2018, via intramuscular route in the left deltoid on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported that last years vaccine in the refrigerator was there and the Medical Assistant inadvertently gave the wrong one. It was reported that the patient did not experience any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.
2 days post vax cough, low temp-101-102;croupy dry cough, crying for 24hr, fever comes & goes-condition persists-used steam & warm apple juice seemed to help relieve pt;
Information has been received from a mother concerning her 9 year old son whose 12 month old cousin was vaccinated with varicella vaccine. Subsequently, the pt developed itchy rash all over his body after swimming in a pool with his cousin. The pt did not have a fever or any other symptoms. The pt did not seek medical attention. The pt's mother did not remember if the pt had chicken pox or not. Additional info has been requested.
CARDIAC ARREST; HYPOTHERMIA; HER BG WAS LOW; DIARRHEA; NAUSEA; FELT SOMETHING WAS GOING THROUGH HER BODY; SLIGHT HEADACHE; 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 bypass, and concurrent conditions included type 1 diabetes mellitus (T1DM), and heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021 after receiving the vaccine, the patient felt something was going through her body for 45 minutes. She experienced nausea and a slight headache. On 18-MAR-2021, she felt fine. On 29-MAR-2021, she woke up middle on the night and felt he blood glucose (BG) was low (T1DM). Later she woke up again and experienced nausea and drank juice. She developed diarrhea and sever chest pain. The ambulance arrived, her body temperature was 93.7 degrees F, her BG was 54 mg/dL. She developed cardiac arrest and admitted to the hospital for 3 day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest, hypothermia, diarrhea, nausea, and felt something was going through her body, and slight headache on 18-MAR-2021, and the outcome of her BG was low was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210503747-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST, HYPOTHERMIA, HER BG WAS LOW. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210503747-COVID-19 VACCINE AD26.COV2.S-DIARRHEA. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210503747-COVID-19 VACCINE AD26.COV2.S-NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.
Swelling and aches in both hands without pre-existing trauma, joint aches in bilateral hips and knees, carpel tunnel symptoms in both hands, swelling and redness in right hand.
Breaking out in rash on both arms from sholder and down entire arm.  Taking benedryl for treatment.
pt recvd vax & became slightly weak & flu-like symptoms; generalized pains & aches;
Fevers, headache, fatigue, myalgia about 12 hours after vaccine.
p/vax pt noticed 2/3 of lt arm was reddened, swollen, warm & tender to touch;no further systemic sx;
This is a spontaneous report received from a contactable reporter  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING (non-serious), BACK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "Pain in their back and shoulders as well as swelling".  Additional information: caller also wants to know : If any seniors have had big time pain in their back and shoulders as well as swelling. Caller would like a list of the reported side effects/adverse events for her own behalf at this time. She states she is "having a rough time with this." Caller stated that her "phone is hacked due to attempted drug sales due to a felony drug charge, her phone is hacked by a criminal." No medical information provided to caller during phone call. I was speaking to Withheld earlier and was telling her about a bad reaction I had to the Pfizer COVID shot and I forgot to tell her about one other symptom.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt was seen by Dr. on 11/25/14 and given injection. He had pain later that day and was seen in ER. Pt had pain and decreased ROM, diagnosed with bursitis due to placement of injection. Pt. followed-up with PA and pt states slight pain but better ROM. Pt lose time from work from 11/26/14-12/3/14.
Fever,body aches, headaches, stomach ache, chills, nausea.
fever of 102; Feeling sore; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever of 102), pain (Verbatim: Feeling sore) and sickness (Verbatim: Sick). The outcome of the fever, pain and sickness were not reported.   It was unknown if the reporter considered the fever, pain and sickness to be related to Shingrix.     It was unknown if the company considered the fever, pain and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUL-2023 The patient received first Shingrix vaccine and had 102 fever. He/she was feeling sore and was sick. He/she asked if one vaccine dose was effective.