chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an actually 15 days normal infant male patient who was expose through his mother who was vaccinated with VARIVAX (Merck) (0.5 ml dose once, SC) (lot number 671080/0828AA, exp: 06/02/2013) on 11-NOV-2011, during pregnancy. The patient was born in 38 weeks from last menstrual period. The patient was reported as small for gestational age. The outcome was not reported. The mother experienced severe preeclampsia and uterine atony during labor/delivery. The mother case was included in the MARRS # 1201USA03414. Additional information is not expected.
Felt Weak; Felt dizzy; Felt Nauseas; Had Chills; Had Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy), NAUSEA (Felt Nauseas), CHILLS (Had Chills) and PYREXIA (Had Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Had Chills) and PYREXIA (Had Fever). On 02-Apr-2021, the patient experienced ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy) and NAUSEA (Felt Nauseas). On 03-Apr-2021, ASTHENIA (Felt Weak), DIZZINESS (Felt dizzy), NAUSEA (Felt Nauseas), CHILLS (Had Chills) and PYREXIA (Had Fever) had resolved.            The patient called to report possible adverse events that they experienced post receiving their second dose. On the same day, 01-Apr-2021 the patient experienced chills and fever. On 02-Apr-2021, the patient felt dizzy, weak, and nauseas. On 03-Apr-2021, the patient reported all of these adverse events subsided.  No Concomitant product use was reported.  The patient didn't take any treatment medication but drank some ginger ale to help with nausea.  Action taken with mRNA-1273 in response to the event was not applicable.
Local reaction to IMM. Left deltoid x 2 days. BENADRYL 1 1/4 tsp po q 4-6 hours prn.
Pt was admitted to ED with a possible febrile seizure. Pt received flu vaccine from unspecified clinic on 8/14/2010. Seizure lasted approximately 8 minutes. EMS administered IN Versed on the scene. Mom had given Tylenol on 8/14/2010 for possible fever after flu vaccine but pt's temp was 37.6 on arrival.
5/23 20y.o. male with history of asthma (intubation x4), eosinophilic esophagitis, lumbar laminectomy, obesity, HTN, bipolar disorder who presents for cough and dyspnea.
Left arm pain 4 days later after receiving vaccination. Advised to take Motrin and cold packs and to avoid use of extremity for a couple of days. His discomfort was moderate.
pt recv vax;all body ached, T 102;arm were shot given severely painful;felt weak all over;v & stomach pains;pt fine for physical exam until vax given;
On Aug 13 I had severe headache follow ed by nausea and heavy vomitinh  I spent the afternoon in ER - got IV for the pain and vommitting On Aug 24 I had weird and strong pain and trembling in left leg
Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the unspecified number of patients have received a dose of GARDASIL (dose, route and lot number were not provided) off schedule on unspecified dates. No adverse symptoms reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned on this report. Additional information will be provided if available. Additional information has been requested.
flu like symptoms; fever; chills; nausea; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unspecified day and had no issues).   On 16th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, nausea and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, fever, chills, nausea and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, nausea and general body pain to be related to Shingrix.  Additional details were provided as follows.  This case was reported by the patient's husband. The patient was vaccinated in the afternoon day before the reporting. On 17th December 2019, the patient awoke early morning with fever, chills, nausea and body aches and also reported flu like symptoms. The pharmacy was called and the patient was recommended tylenol. The reporter called GlaxoSmithKline and seeked advice on how to treat symptoms.  The reporter was referred to the patient's physician and the call center reviewed prescribing information for common side effects and median duration of time of events in clinical trials.
Information has been received from a registered nurse concerning a 14 year old female patient with a history of pre-eclampsia and BELL's palsy during a prior pregnancy who on 04-FEB-2009 was vaccinated with the first IM dose of GARDASIL (655618/0186U) while she was pregnant. A pregnancy test and prenatal blood screen were performed. Her last menstrual period was 10-JAN-2009 and the estimated delivery date is 17-OCT-2009. The patient was started on prenatal vitamins (unspecified) and iron (unspecified). No adverse effect was reported. Follow-up information has been received from a registered nurse concerning the patient. It was reported that the patient was diagnosed with tubal pregnancy. The patient was admitted to the hospital the week of 16-FEB-2009 and a therapeutic abortion was performed. The date of the surgery was unavailable. On 04-MAR-2009 the patient was seen in the office and had fully recovered. Additional information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L027076 and expiration date 25-MAY-2017, lot # L039141 and expiration date 16-AUG-2017, orally; exact doses were not reported). It was reported that the vaccine were exposed to a temperature excursion described as minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Headache, drowsiness , body aches -  24 hours Sore Arm - 48 hours
Leg at injection site warm and sore day after injection, had softball size red area around injection site by that night (mom outlined with black marker), redness had extended past outline a little bit by next morning. Brother had same vaccine at the same time with no reaction.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 21 year old male. 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, intramuscular, and batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211038507 and 20211038614.
Day after injection L deltoid numbness tingling L 4-5 fingers - up arm L and later in day "tingling Rt 4th and 5th fingers" small spot numbness upper lip.
Legs got weaker trouble walking/using cane then walker now having physical therapy starting 10/13/17 5 days infusion in hospital of unknown meds diagnosis: Guillain-Barre Syndrome.
Fast heartbeat; Feels like pure adrenaline pumping through body wired tense sensation; Pain like fire in ears; Pain in throat; Nose pain; Strange headache; Muscle soreness; insomnia; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 02Apr2021 at 11:00(at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disorder, hypotension, rheumatoid arthritis and rheumatoid arthritis. Concomitant medications included withania somnifera (ASHWAGANDHA), sambucus nigra (IMMUNITY), probiotic (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), all started on unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 15:00, the patient experienced feel like pure adrenaline pumping through body wired tense sensation, pain like fire in ears, muscle soreness, fast heartbeat., pain in throat, nose pain, strange headache. Two days later now, the patient felt like it must come off 3-day meth binge. The patient did not receive any treatment for events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event weird feeling, pain like fire in ears, muscle soreness, fast heartbeat, pain in throat, nose pain, strange headache was recovering.  No follow-up attempts are needed. No further information is expected.
sore arm; lazy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LAZINESS (lazy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and LAZINESS (lazy). At the time of the report, PAIN IN EXTREMITY (sore arm) and LAZINESS (lazy) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up , Contact information updated.
the patient is not currently experiencing symptoms; patient (17 years old) accidentally received the MMRII vaccine, which she had previously in infancy/ early childhood; patient (17 years old) accidentally received the MMRII vaccine, which she had previously in infancy/ early childhood; This spontaneous report was received from a registered nurse and refers to a 17-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-SEP-2020, the patient was accidentally vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 injection, lot # S018593, expiration date 17-JUN-2021 (exact dose, vaccination site and route of administration were not provided) for prophylaxis, which she had previously received in infancy/ early childhood. The patient was not experiencing symptoms at the reporting time.
A few minutes after receiving vaccine patient began to have irritation in throat and tightness in the chest. 911 was called. 50 mg of diphenhydramine was given to patient with their consent and denied any allergy to benadryl. Counseled patient that benadryl could cause drowsiness. Patient denied any history of anaphylaxis in the past. The EMTs arrived and took over care. Vitals were good per EMT's. The EMTs escorted patient from the pharmacy. Per the EMTs, the patient was advised to self-monitor at home and seek medical attention if any worsening of symptoms, and they advised the patient not to drive home, and alternate transportation was arranged.
they did not give him the booster but gave him the 2nd vaccine instead; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 3, (booster), single (Lot number: FK9895) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, lot: 30155BA), administration date: 26Oct2021, when the patient was 12-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, They did not put the lot on his card for that dose), administration date: 19Nov2021, when the patient was 12-year-old, for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 14Apr2022, outcome "unknown", described as "they did not give him the booster but gave him the 2nd vaccine instead"; HEADACHE (non-serious) with onset Apr2022, outcome "unknown".  Additional information: Reporter stated that it is really upsetting that there was a confusion on the Pfizer BioNTech Covid-19 Vaccine ad-ministered to her grandson who "received the second shot instead of the booster". Reporter also stated that now her grandson is even more upset and will not go back to his doctor's office since he didn't really want to get the vaccine. Prior Vaccinations (within 4 weeks): None. States she took her grandson to get the booster shot on 14Apr2022 and they did not give him the booster but gave him the 2nd vaccine instead and thought he was supposed to get the 2nd dose that day but they were there for him to get the booster dose; states they made an error and she does not know what they did now and she is really concerned they made the mistake and does not know what they were giving him but he did have his vaccine card with him; reporter asks if all three doses of the vaccine are the same. Reporter states she is upset that they did this and now won't be going back there and they made this mistake and they said it was ok and to her this was not a little mistake. States the patient had the 1st dose of the Pfizer Vaccine on 26Oct2021 with lot 30155BA, his 2nd dose of the vaccine on 19Nov2021 and they did not put the lot on his card for that dose and the third dose on 14Apr2022 and the lot is FK9895 for that dose. States the patient just got a really bad headache after the vaccine and she gave him Tylenol and he laid down and she gave him a lot of fluids. No follow-up attempts are possible. No further information is expected.
Two hours after immunization, patient developed redness and swelling of MCP joints of hands; blotchy erythematous rash from hands to elbows; erythema to face neck and ears. Symptoms lasted approximately 8 hours, went away after taking Benadryl.
Mild Flu like symptoms, chest congestion, pink eye like symptoms,  runny/congestion of the nose, sore/scratchy throat starting approximately 24-36 hours after running for 7days. Now neck pains then right ear ache/tinnitus
I had the flu shot on 11/21/2019 within days I started having issues breathing and called my OB who advised me to speak to my PCP regarding this issue. On 12/23/2019 I messaged my OB to advise my PCP referred me to a Pulmonologist. The Pulmonologist then diagnosed me with acute asthma. No diagnosed history of asthma before and started within days of my flu shot vaccine.
Pt says within about 15 minutes of vaccine, she had tingling in hands and feet, tingling in her upper lip, and she felt like there was a rubber band around her head.  I ave her water and referred her to the urgent care next door. When I followed up with her today (5.3), she says the symptoms self-resolved and she never received any actual medical attention
Feverish 1pm following day Took 3,000 mg vitamin C and 2 Acetaminophen tablets Color turned pale/gray, lips lost all color, threw up 3 times between  5pm-9pm. Had severe chills after vomiting. Had congestion in chest and was taking deep breaths to breathe.  Took pepto bismol at 9pm, ate some saltine crackers, and drank some Gatorade. Took 1 ibuprofen at 10pm, then slept for 11 hours. Woke up at 9am on 9/12/21. Got out of bed at 10am.  Feeling  better but still feeling out of breath and not breathing normally..
Pt received COVID 19 Booster shot today during annual wellness exam. Medical assistant that administered vaccine realized after administering that dose was expired. The dose that patient received was prepared and expired on 1/25/22. Vaccine was administered on 1/26/22. Clinic nursing supervisor contacted patient's mother and informed her that pt received expired vaccine which is considered invalid and would need to be repeated. pt's mother verbalized understanding
fever 102.6- dx w/ pneumonia.  treated w/ ampicillin 500 mg-56 pills
Sleep most of the first day; Unsteady on her feet; Cough; Quite fatigued; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleep most of the first day), LIMB DISCOMFORT (Unsteady on her feet), COUGH (Cough), FATIGUE (Quite fatigued) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Alzheimer's disease and Pulmonary embolism. Concomitant products included RIVAROXABAN (XARELTO ) for Pulmonary embolism.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Sleep most of the first day), LIMB DISCOMFORT (Unsteady on her feet), COUGH (Cough), FATIGUE (Quite fatigued) and CHILLS (Chills). On 02-Mar-2021, SOMNOLENCE (Sleep most of the first day), LIMB DISCOMFORT (Unsteady on her feet), FATIGUE (Quite fatigued) and CHILLS (Chills) outcome was unknown. At the time of the report, COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: pulmonary embolism (Inconclusive) CAT scan done in the hospital which showed a pulmonary embolism which is not known if that was a result of the COVID-19 infection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Treatment medication information is not provided.
Patient had first dose of Moderna COVID-19 vaccine on 3/12/21. She was admitted to our hospital on 11/19/21 and consented to receive second dose Moderna on discharge. She was discharged on 11/27/21. The nurse came to the pharmacy and was given a Pfizer vial to draw up the vaccine. The patient received Pfizer vaccine instead of Moderna. The patient has been notified and is scheduled to receive second dose Moderna on 12/19/21.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A 79 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were none. On 11Jan2021 the patient was tested positive for COVID 19. He was sick before then but did not get tested until 11Jan2021. Events outcome was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. He was sick before then but did not get tested until 11Jan2021.,Linked Report(s) : US-PFIZER INC-2021021527 same reporter/drug/AE, different patient
Pain, itching, peeling skin, and discoloration of injected arm slightly below injection site.
sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy"; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: FH8020), administration date: 21Oct2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown". Additional information: Patient rarely had even mild reactions (sore shoulder; a day of lethargy) after each dose.
PATIENT CALLED STORE AND COMPLAINED OF NAUSEA AND DIZZINESS. SHOT WAS GIVEN 8/27/19 2:15PM AND SHE EXPERIENCED SYMPTOMS 8/28/19 IN MORNING TIME. PATIENT ALSO SAID SHE EXERCISED RIGHT BEFORE IN BED THEN GOT DIZZY/NAUSEATED WHEN GETTING UP.  PATIENT DID NOT HAVE A BLOOD PRESSURE MACHINE OR GLUCOMETER TO CHECK LEVELS. PATIENT LOGGED A CALL TO MD AND WILL CALL HOSP IF SYMPTOMS WORSEN