chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax & 1 hrs later devel nausea, facial numbness & couldn't think straight which lasted for about 1 hrs; took DPH; also nausea;
This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with PNEUMOVAX 23 [Lot# L002310, Expiry date: 08-JUN-2016] which were exposed to temperatures outside of the recommended range. No adverse event were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt. was administered H1N1 flu vaccine intranasal instead of intra muscular no symptoms of flu noted as of 12/16/09. Thinking that this is protocol no MD order in place.
lt arm swelling & pain w/redness knot in deltoid & goes down the arm;warm to touch;started 2 days p/shot;DPH,APAP, seldane x 1wk, warm compresses;
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX (batch number B37G7, expiry date 23rd May 2021) for prophylaxis. On 23rd January 2019, the patient received SHINGRIX (intramuscular). On 23rd January 2019, 1 sec after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On 28th January 2019, the patient experienced burning skin. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the burning skin was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, pain in arm and burning skin to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other healthcare professional for herself. The patient received SHINGRIX on left deltoid. The patient immediately felt the pain of the needle in her left upper arm. 2 hours after receiving SHINGRIX, the patient's arm was sore for about 5 days and then resolved. 5 days after receiving SHINGRIX, the patient began to experience skin burning beginning in the anterior upper arms and face. The burning was spreading to other unspecified parts. At time of reporting, the burning has become worse. The reporter consented to follow up.
DTAP given on 8-11-09 Hives on 8-13-09 Benadryl + Zyrtec.
Client presented  to receive Pfizer Booster and Flucelvax. At approximately 1418 Client was in observation area when client let  RN know that he felt mild swelling on front side of arm as well as some numbness. Client had received the flu vaccine on the Right arm. Client was AAOx3 and denied shortness of breath, trouble swallowing. Client stated he had mild itching on right arm. Client denies having a reaction to previous doses. At 1425Vitals taken by RN BP 158/88 HR 95 02 99 RR 20. At 1430 Oral Benadryl 50mg was given and client self-administered. Client states he had food and water prior to vaccination. Client moved to zero gravity chair without assistance. Client denies having any previous reactions to vaccines. 1340 Vitals BP 158/88 HR8702 99 RR 20. Client has a history of High blood pressure, and high cholesterol and is currently on medications. Client has no known allergies. At 1342 client stated the itching was gone and the swelling was going down. 1445 vitals BP 156/92 HR 87 02 97 RR 18. 1450 Vitals at 1450 BP 156/96 HR 85 02 98 RR18.  At 1455 RN asked client on how client was feeling. Client stated he was feeling better, he had no more swelling, or itching only soreness. Client was ready to go home. RN gave client Emergency room precautions in case any of the symptoms came back or worsened. Follow up with Primary care provider in 24 hrs. was recommended. Client verbalized understanding. Client stated his dad would drive him home. Client left vaccination area with a steady gait at 1455.
Two weeks after the first dose, I started experiencing restless leg type symptoms at night. Resulting in waking up every night in the middle of the night with uncomfortable feeling in legs, pins and needles. 12 hours after the second dose (12/19/2021), experienced severe Charlie Horse cramps in calve muscles along with flu like symptoms (fever, chills, body aches). Worst of the muscle cramping ended by the next morning, however every night since then I am walking up in the middle of the night with muscle aches, twitching, pins and needles in calves (both legs). In the morning, calves feel like bricks, very stiff, throughout the day experience pins and needles in legs.
High pitched screaming, arched back, inconsolable, low grade fever - continued for approximately two days.  11/02 fever of 101 rectally. 11/03 temperature returned to nml. 11/03 - 11/04 given IV antibiotics. Infant afebrile. Progress notes indicated "suspect fever secondary to Hep B" vax. At present time this pt suffers from multiple allergies.
Patient developed fever and pleuropericarditis. He required hospitalization x several days and underwent thoracotomy and pericardial window
Guillan-Barre syndrome; This spontaneous report was received from an office manager via a company representative and refers to a female patient of unknown age (an office manager's friend's daughter). The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (lot number and expiry date were not reported) for prophylaxis.  On an unknown date, after a dose of the vaccine, the patient experienced Guillain-Barre syndrome. The current status of the patient and the outcome of the event were unknown.  The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of Guillain-Barre syndrome was determined to be medically significant.
12/12/22 presents to ED for "altered mental status". PMHx of "CLL, Parkinson's, bladder ca, CKD"
This spontaneous report as received from a nurse refers to a 9 week old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Per patient, in order of appearance: "fatigue, genital herpes II outbreak in 24 hours, severe total body pain, headache, fever of 101.5, allergic reaction (difficulty breathing, throat closing). Treated in ER with IV and three IV meds".
Heart attack; Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2, first single dose via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW0180) as for covid-19 immunisation. Medical history included heart problem. Concomitant medication included levetiracetam (KEPPRA). The patient had a serious reaction to your product. The patient was started having chest pain and shortness of breath after medical on 14Jul2021. She had lab work done at the hospital to check her heart and stuff on 14Jul2021. The patient was kept in hospital for 15 hours after she had heart 'attack' on 14Jul2021. The patient received 'Retinol' and Nitroglycerin last night and then received the Nitro drip and fluids last night and in this morning and this afternoon. At the time of this report, it's better since she had Nitro drip. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Very severe flu-like symptoms with extreme body aches in almost all joints, nausea, stomach issues, extreme fatigue, unable to sleep last night because of the pain in joints.
BODY CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (BODY CHILLS) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CHILLS (BODY CHILLS). At the time of the report, CHILLS (BODY CHILLS) had resolved.            Concomitant product use was not provided by the reporter.  The patient's second vaccine caused body chills. The patient's body created too many antibodies against Humira. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624375, MOD-2022-624376 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow up: Received updates to event information, reporter opinion of causality and narrative description.
Patient presented in office @ 1030 with edema to R upper arm, erythemic, warm to touch, low-grade fever. Patient states it is very painful, reports no other symptoms.
2 days post vax presented to office w/T101-103, 24hr vomit, diarrhea, w/5-7 days abd cramping;
SICK; This spontaneous report received from a patient via social media through a company representative 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 expiry: Unknown) dose, start therapy date were not reported 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 an unspecified date, upon vaccination the patient was sick and hospitalized for two days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509801-COVID-19 VACCINE AD26.COV2.S-Sick. 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).
I had no fever or nauseas, but two days after the vaccine I had pain in my right armpit. I checked the armpit and discovered a lump. The pain lasted for about a week. The lump of swollen lymph nodes were there for about 3 weeks. I also cought covid for the 2nd time but I wear a mask everywhere I go so I don't know how I was exposed. I started with a slight cough then it progressed badly to a bad cough. I went to the doctor and had a positive covid test. I had drainage and severe coughs. I also got short of breath. I tried to get the covid infusion but I didn't qualify for it. I've been doing breathing treatments every 4 hours. I was prescribed prednisone. I was off work for 2 weeks.
Severe body aches fever reaching 101.5 chills headache fatigue felt like severe case of flu Started six hours after shot.  Fever lasted twelve hours headache and body aches lasted 2days Day 3 still feel fatigue
08/27/22 presents to EC ED for "chest pain". PMHx of "CAD, DM, lower extremity edema, and arthritis"
Overall uncomfortable after the administration of VAXELIS; Warm to touch; 3.5 cm of redness induration and also warm to touch; Red spot at the VAXELIS injection site; Crying more than usual; Significant fever; This non-serious spontaneous safety report with agency reference #02151156 was received via partner on 20-APR-2022 and forwarded to agency on 21-APR-2022, from a Health Care Professional.  The reporter did not assess the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever'.  It was reported that the PCV 13 Vaccine was administered the same day (on the opposite thigh) as VAXELIS. It was considered as co-suspect given that the patient experienced  'crying more than usual', and 'significant fever'. Nonetheless, PCV 13 was concomitant for the other reported adverse events.  Further information is expected.   Significant follow-up was received via fax by agency on 12-MAY-2022, from a Health Care Professional.  The reporter confirmed that the events were not serious. First dose of Vaxelis was administered on 12-NOV-2021. Second dose was administered on12-JAN-2022.  End date and outcome of events were provided.  The patient was treated with analgesic for pain, and cool or warm compresses.  The reporter assessed the causal relationship between Vaxelis and the events 'overall uncomfortable after the administration of VAXELIS', 'warm to touch', '3.5 cm of redness induration and also warm to touch', 'red spot at the VAXELIS injection site', 'crying more than usual' and 'significant fever' as related.  This case is maintained as non-serious.  No further information is expected.
Cough 2 days Fever 1 day Chills 1 day Dizzyness 2 days Headache 3 days Ey e Pain 3 days
I was initially Asymptomatic when I tested positive first on 06/24/2022. I had symptoms of congestion, cough, and fatigue develop on 07/01/2022. I received Monoclonal Antibodies on 06/24/2022. Once my symptoms developed I was ill for 10 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Large indurated area (deep red) 3.5cm x 5cm with surrounding pink nonindurated area 6.5x9cm. Itching & painful in center. Was given cefadroxil 500mg/5ml 1 tsp PO BID for 10 days.
COVD break through Case. I received my 1st booster shot on 11/24/2021 and My COVID symptoms started on 01/26/2022 in the morning around 8:00AM I had tinging sensations in my throat. On 01/27/2022 I did a home COVID test and a PCR which both were positive. I lost taste and smell for 3 days.  It came back after 3 days. I had low fever, nasal congestion, tires, exhausted, a little shivering. 01/28/2022- nasal congestion remained, low fever lasted for couple of days. I had no sore throat. But the nasal congestions was very annoyed. After 9 days I tested negative, when I tested positive I took Tylenol but after several weeks I had to see a specialist due to the nasal congestion which was worse and annoying and Tylenol wasn't helping. I even took several over the counter meds like allergy relief which helped little but it came back. So the specialist told me to do nasal rinses with budesonide ( inhaler) which really helped. I was better off within few days. I am recovering slowly and I do see improvements.
her husband had his booster dose yesterday; Temperature of 104.4 degrees Farenheight; Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site). At the time of the report, OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment product information was not provided. Concomitant product use was not provided.   This case was linked to MOD-2021-297362, MOD-2021-297493 (Patient Link).
BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company has requested to follow-up for batch number.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and fatigue. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and body ache was not reported. This report was non-serious.
This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored GARDASIL (lot # K011562, expiry date 08-APR-2017) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports receive from the same reporter. Additional information has been requested.
Child dx'd with chickenpox per ER physician. Mother states he has small pustules, not yet crusted, but "somewhat itchy".
My daughter started to get fussy after dinner. She cried for about a half an hour straight about nothing. I took her temp and it was slightly elevated just over 99.3. Since she has pulmonary hypertension and on oxygen we tested her oxygen level which was normal at 98 but her heart rate was at 150. Baseline max heart rate for her is 112. Gave TYLENOL. She finally fell asleep but slept horrible that evening. Woke up the next morning and fever was gone and heart rate was back in normal range.
6/2 Things started with a scratch throat, fatigue and diarrhea with chills coming in that evening.  6/3 I had extreme fatigue, nasal congestion and cough.  Pressure on ears felt internally, like I was getting an ear infection.  6/4 Head congestion continued and I took Benadryl and the congestion drifted to the chest.  6/5 televisit with doctor who proscribed paxlovid.  This continued until day 8, when I started to fell better.
Treatment for hypertension and hyperlipidemia under good control. Felt well prior to and following 3/25/21 vaccination. At 7:25 AM on 3/26/21 passed out on floor causing a closed distal radius fracture of the right wrist. After emergency treatment, PCP followed up with tests and specialists with no negative outcomes detected. Orthopedic treatment and Hand Rehabilitation ongoing.
On June 23, 2020, the donor called the center to report that he developed a fever, beginning the evening of June 17, 2020, that continued through June 21, 2020.  The donor had consulted his physician by phone and was advised that it could be a reaction to the vaccine.  When the donor also lost his sense of taste on June 21, he decided to get tested for COVID-19.  Donor received a positive test result on June 24.  On the June 23 call, the donor also disclosed, for the first time, that he had had a reaction that involved shortness of breath, chest tightness, and a mild cough after his first shot.  It is not clear whether the donor's symptoms are attributable to the vaccine or COVID-19.  Therefore, out of an abundance of caution, we are submitting this report.
pt says on 3/27/2021 she started to get warm, clammy and damp.  On 3/28/2021 she had SOB.  She had  swelling and pain in her lower stomach that was persistent and would not go away.  Her temp was climbing reaching  99.9 .  She did not eat but only drank water.  She was feeling uncomfortable.  She started sweating.  Next morning  3/29/2021 she woke up w/ chills and vomiting.   She vomited liquid only. She took Ibuprofen which helped w/ the chills and stomach pain.   On 3/31/2021 her left shoulder started hurting once again like it did right after taking the shot.  BP was 151/95 and pulse was 127.  She still has all the other symptoms at this time with additional pain on her left side. She started feeling more like herself by 4/4/2021.  Today 4/7/2021 pulse is 82.  BP is 130/83.  Pt will see her PCP and discuss getting the 2nd dose.