chrisvoncsefalvay/vaers-outcomes huggingface dataset:
102F Fever since 12/18, chills, fatigue, body aches, vomiting, swollen neck/lymph nodes, severe headache. Self-medicated with Tylenol
onset was 4 days after the vaccination, 01/15/2021, swollen knots on my shoulder, under arms and the concerning one was on my clavicle bone. It hurt to the touch. I did not receive any medication. I had an chest x-ray, blood work and ultrasound and the results were normal. I came back and repeated the blood work after 2 or 3 weeks, and the results were normal. The swollen knots on my clavicle lasted about 6 weeks. It went away on it's own.
No additional AE; Vaccines were administered after a temperature excursion; Information has been received from a vaccine coordinator, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally (lot number and expiration date were not reported) or was vaccinated with an improperly dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U008181, expiration date 08-FEB-2023 (anatomical location and administration route were not reported) both vaccines for prophylaxis. No adverse effects were reported.  The vaccines had temperature excursions of 14 Fahrenheit degrees (F) 39,6 F, during a time frame of 30 hours 15 minutes and 0 hours 45 minutes.
Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of leg not getting any better, saw Doctor who ordered Ultra sound of left leg and CT scan of lungs. Extensive DVT clot found in left leg, low density bi lateral pulmonary embolism in both lower lobes of lungs found from CT scan. Hospital stay for 2 days, Heparin given in hospital and now I'm on eliquis blood thinner. Had gotten my second Pfizer shot 3 days before admittance to hospital.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: vaccine expired-Mild, Additional Details: vaccine expired
chills; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program, . This male patient of unspecified age received the first dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 10Mar2021, 4 days after vaccination, the patient experienced chills. The patient inquired if this was normal. The clinical outcome of chills was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
01/4  Injection - Usual Soreness   (Employee believes the following S&S are r/t vaccine, will f/u PMD)  01/14/2021:  A.M.  Experienced soreness, achiness and periodic sharp pain in Rt Foot. Symptoms present today.  No H/O injury. Tylenol for pain.  01/18 /2021:   2 pm - Extreme Itching on Rt Shoulder and Chest     8 pm - Itchy Rash on Rt Shoulder and Chest.  Itching present today, scabe on shoulder,  3 papules on chest - No change in hygiene, cleaning or food products.  No known contact with irritates, No Tx.
On day 9 s/p primary vaccinia administration, patient developed a 4mm satellite eruption, 1.5cm sup/posterior to primary response site. No adenopahty, fever or systemic sx. No other systemic rash. + evid contact dermatitis 2 hours to adhesive tape. Recommended increased wound management education to care.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 01/11/2021, 02/01/2021, and 11/17/2021. They tested positive for COVID-19 on 01/25/2022. They were tested because they had a known COVID-19 exposure. The individual was described as asymptomatic at the time of the test. The  individual died on 02/06/2022. COVID-19 is listed on the death certificate.
Patient began feeling achy with a headache, but not feverish around 5pm.  Tried to eat dinner, but continued to feel ill and went to lay down.  She had the chills with a 101 degree fever.  She had a severe headache with light sensitivity and nausea for 2 days after vaccination.  Her left arm, where she received the vaccination swelled up about the size of an egg and had sharp pain and hot to the touch all the way to her elbow.
Patient was administered with only the liquid DTap-IPV portion of the Pentacel vaccine and did not received the ActHib portion/No AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves female patient (unknown demographics) who was administered with 0.5 mL  dose of only the liquid Dtap-IPV portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination and she did not received the ActHib portion (product preparation issue) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to inappropriate reconstitution technique. It was reported that when administering Pentacel vaccine only the liquid portion gets injected.  At a time of reporting no adverse event reported.  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.  There will be no information available on the batch number for this case.
10/12 onset with tightness when opening mouth to eat, progressed to unilateral swelling of R side of face. Associated with fatigue, ear congestion and sore throat when drinking acidic beverages.  Presented 10/15 for assessment, afebrile 98.5 oral,  noted R sided parotitis- moderate, questionable L sided parotitis-vey mild. Injection site normal. Advised NSAID, acetaminophen, hydration, rest. Advised to work from home until parotitis resolves ( approx. 5-7d from onset) providing also afebrile. Advised pcp f/u for further evaluation as needed. Advised to seek emergency tx if worsening sx including abdominal pain, testicular symptoms.
Patient is fully vaccinated.  COVID + at ed visit on 12/28/2021.  chief complaint vomiting, headache.  40-year-old female with history of extensive coronary artery disease presents to the emergency Department with complaints of 5 days of body aches, nausea, vomiting, headache, cough. does not have any specific sick contacts. Patient states she has been taking Tylenol and ibuprofen for her symptoms. Patient states she is not on blood thinners, has no numbness, weakness, syncope, no head trauma.BP 137/90  | Pulse 96  | Temp 99 °F (37.2 °C) (Oral)  | Resp 17  | Ht 170.2 cm (5' 7")  | Wt 95.3 kg (210 lb)  | LMP 12/14/2021  | SpO2 97%  | BMI 32.89 kg/m² Chest wall: Tenderness> Imaging: No definite fracture or pneumothorax.we'll refer patient to infusion clinic to see if she qualifies. Recommend patient Motrin, Zofran at home. Patient to return to emergency room if shortness of breath worsens. Discharged from ED.
Fatigue,headache,muscle pain,joint pain,chills,a fast heartbeat, palpitations, dizziness and weakness
Upper lips was very swollen from left to right; This is a spontaneous report from a contactable consumer (reporter's husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6207), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced upper lips was very swollen from left to right. Reporter stated, we had our first vaccine (Covid Vaccine). Reporter husband, his upper lips was very swollen from left to right and he put ice on it and then Benadryl (Treatment) and that lasted for about a day and the next morning it was okay. So, reporter was wondering, is there anything related to this with the second vaccine. Therapeutic measures were taken as a result of upper lips was very swollen from left to right. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible, no further information is expected.
This spontaneous report was received from a physician regarding a 19 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB(reported as Hib) lot# reported as UI645AA and expiration date 21-JUL-2017 (dose, route and frequency were not reported) and VAQTA (reported as Hep A) lot# reported as M015290 and expiration date 20-SEP-2017 (dose, route and frequency were not reported) for prophylaxis, when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Client reports symptoms of severe abdominal cramping and nausea started around  midnight following afternoon immunization with Moderna Covid vaccine.  Cramping would come and go and were severe. Client states he did what he could to put up with the pain until Monday Feb 15th. He went to local ER. Client was unable to tolerate CT contrast oral liquid (caused immediate diarrhea) so an abdominal CT scan was not completed and he was discharged. Symptoms still persist and client states he lost 16 lbs so far. He has reached out to follow up with his regular HCP- VA clinic.  He is waiting for a call from them today.
parent noticed 2 days p/vax rt leg was red & swollen;today on exam rt leg has reddened area approx size of tennis ball, hot to touch;parent has been giving child APAP & holding cold, wet cloth on area;
painful leg pain; joint stiffness; muscle ache; 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 PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   In March 2021, the patient experienced PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache). At the time of the report, PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-162185 (Patient Link).
Swollen lymph nodes; most severe swelling in left axilla (size of plum) that lasted approximately five days, and was noticeable two/three days after booster injection.  Injection site swelling was adjacent to injection site, was more painful than first two shots, and was hotter and more painful, too.  After swelling near injection site resolved after about four or five days, then swelling in left axilla lymph node also started to resolve more quickly, too (decreased swelling incrementally decreased each day).
OUTBEAK OF THREE COLD SORES AROUND UPPER AND LOWER LIP AREA; IN ONE DAY ONE MORE COLD SORE DEVELOPED
Red Rash on arms. Since vaccination, have had fever, chills, muscle achiness (whole body) tired dizzy, leg weakness, headache. Most resolved, then rash on third day. Seems to be dissipating after two hours.
body pain; Headache; nausea; pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection). The patient was treated with ACETAMINOPHEN 500mg at an unknown frequency. At the time of the report, PAIN (body pain), HEADACHE (Headache), NAUSEA (nausea) and INJECTION SITE PAIN (pain at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Started with muscle aches, temperature @ 11pm was 103.8 degrees decreased 101.8 degrees with Tylenol, started having aches and chills, started sweating, continued with muscle aches and unable to get out of bed next day.
Transverse myelitis, hospitalization, workup is in progress but recent vaccination was noted.
shipment of Flublok received late and the stability of the vaccine could not be verified, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA282000 and 2019SA281960 (same reporter).  This case involves a 85 years old female patient who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via unknown route in unknown administration site on 07-Oct-2019 (reported as yesterday).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  Patient had no adverse reaction.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 sender: none.
numbness of finger tips of both hands;cont & is due now for dose 3;had tonsillectomy on 31MAY94 w/exam & also seen on 6JUN94;neuro exam revealed nothing;
Nausea- still ongoing; Headache; Dizziness; Stomach pain.
Persistent mild headaches for over two weeks. Have not experienced a headache in the last 10 days. Dizzy spells that are mild and occur two or three times a week since the injection. Last time I felt dizzy for a brief moment was 4 days ago. Shortness of breath when exercising and I still feel it a month later. Prior to the injection I could go 5 to 7 miles of jogging and power walking on trails. The shortness of breath is the most noticeable and is what is somewhat concerning.  I have not been able to complete my normal workout since I took the vacine.
DID NOT SLEEP WELL; WOKE UP SWEATY; GETTING HOT; FEELING CHILLED/CHILLED; FEELING A LITTLE FOGGY/FELT OFF; MORE THIRSTY THAN USUAL; HOT FLASHY; FEELING LITTLE ACHY AND SORE; ACTIVE SHIVER; LOW GRADE FEVER; SORE ARM; LITTLE ENERGY; FATIGUE/TIRED; VACCINATION AT 8TH MONTH OF PREGNANCY; INJECTION SITE SORENESS/STUNG A LITTLE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 13-MAR-2021 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 13-MAR-2021, the subject experienced 8th month of pregnancy. On 13-MAR-2021, the subject experienced injection site soreness/stung a little. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced woke up sweaty. On 14-MAR-2021, the subject experienced getting hot. On 14-MAR-2021, the subject experienced feeling chilled/chilled. On 14-MAR-2021, the subject experienced feeling a little foggy/felt off. On 14-MAR-2021, the subject experienced more thirsty than usual. On 14-MAR-2021, the subject experienced hot flashy. On 14-MAR-2021, the subject experienced feeling little achy and sore. On 14-MAR-2021, the subject experienced active shiver. On 14-MAR-2021, the subject experienced low grade fever. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced little energy. On 14-MAR-2021, the subject experienced fatigue/tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the 8th month of pregnancy, injection site soreness/stung a little, feeling chilled/chilled, active shiver, did not sleep well, woke up sweaty, low grade fever, feeling a little foggy/felt off, fatigue/tired, more thirsty than usual, getting hot, hot flashy, sore arm, feeling little achy and sore and little energy was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330993.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
12MAY pt began having irregular heart beat lasting a few seconds occuring every 5-10min originating @ last 3 days;denies syncope, visual or mental disturbances or other physical c/o;no prev occurances or heart palpatations;
A territory representative reported that a pt received vaccine. On 9/23/00 pt developed swelling at injection site. Follow-up received from the physician on 01/25/2000 indicated that the child received both Acel-Imune and IPV vaccines on 09/28/2000. On 09/30/2000, he developed swelling at an unspecified injection site. He was treated with amoxicillin/clavulanic acid and diphenhydramine. He recovered.
I got COVID twice since having my 3rd dose. The first time that I got 12/17/2021. I received a positive COVID-19 test at my doctors office. I had sore throat, body aches, chills, fever, weakness, and cough. These symptoms lasted from 5-7 days. I did take OTC cold medications with vitamins and drank a lot of fluids. Then, I started getting symptoms of COVID-19 on 05/29/2022. I first took a COVID-19 test that was negative. Then I tested on positive for COVID-19 and my results came back 6/1/2022. I have symptoms of body aches, runny nose, coughing, sneezing, fever, and chills. I have a doctor appointment today by telehealth.
On 2/14/19 patient reported that she was still sore and wasn't sure if it was from the shingles vaccine but that she was going to call her physician that day and would get back to me. On 3/1/19 I called patient to follow up since I hadn't heard from her and she said she had an X-ray that showed a cyst in her shoulder area. It may or may not be related to the vaccine.
Patient felt hot and nauseous almost immediately following vaccination.  Placed ice pack on back of neck, which relieved symptoms.  Patient did vomit small amount.  Blood pressure was recorded at time of symptoms was 98/62.  Symptoms resolved ~5 minuts after onset.
PT. experienced numbness and tingling of the left hand from the shoulder to the finger almost a month after she received the FLUAD and PNEUMOVAX 23 shots. This feeling comes on then disappears. It is not a constant feeling. PT. received the flu shot in the left hand and assumes that this feelings is a result of the flu shot but cannot be certain about that. PT did not visit her doctor or use any medications to treat symptoms.
The pt was in for a well child exam and immunizations on 10/25/00. Infant died on 10/27/00. Cause of Death SIDS
ACHY; COUGH; FEEL LIKE CRAP; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced achy, cough, feel like crap, chills, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, achy, chills, cough, headache and feel like crap was not reported. This report was non-serious.
My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..
no additional information provided/no additional AE reported; a patient was administered ROTATEQ and PEDVAXHIB after a temperature excursion; This spontaneous report has been received from a health business professional referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 02-DEC-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL orally (lot # T033510, expiration date 28-DEC-2021; strength was not reported) and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 mL (lot# T037650, expiration date 21-JUL-2023; strength and route were not reported) for prophylaxis after a temperature excursion. The vaccines were improperly storage at 47.29 F for 3 hours 22 minutes (product storage error). There was not previous temperature excursion. No additional information or adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003366: US-009507513-2112USA003448: US-009507513-2112USA003663: US-009507513-2112USA003663: