chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the 1st & 2nd shot had finger joint swelling and locking; At the 1st & 2nd shot had finger joint swelling and locking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE), administered in arm left, administration date 18Mar2021 (Lot number: EWG150) at the age of 72 years as dose 1, single and administered in arm left, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: FLU. Past drug history included: Statins, reaction(s): "drug allergy"; Erythromycin, reaction(s): "drug allergy". The following information was reported: JOINT SWELLING (non-serious), TRIGGER FINGER (non-serious) all with onset 2021, outcome "unknown" and all described as "At the 1st & 2nd shot had finger joint swelling and locking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This report was received via regulatory authority. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's concomitant medications included blood pressure meds. The lot number for dose 2 was also reported as EN6 (or G) 208. The vaccine was administered in Pharmacy or Drug Store. The patient also received the 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) administered in arm left, administration date 14Oct2021 (Lot number: EWG150) and experienced 6 hours after the 3rd shot, developed finger locking and swelling in the fingers in left hand.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
~30 hrs after vaccine 6-7 cm raised red area over varicella site - Rx BENADRYL - subsided in 24 hrs.
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9.  I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility.   Information regarding batch/lot number has been requested.
got COVID shortly after; got COVID shortly after; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-010540 (Moderna case), 137265 (Moderna AE#), U1075497 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID shortly after". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse practitioner concerning a female with no known allergies who was vaccinated with a dose of Gardasil, Varivax (MSD), MENACTRA and DTaP.  Subsequently, the patient experienced syncope that lasted two to three minutes.  It was reported that the patient required no treatment, hospitalization or resuscitation and had no illness at the time of vaccination.  The patient was recovered.  Additional information has been requested.
Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (route, dose, Lot# and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
pt had rash around injection site and swelling along with fever.  Her arm hurt really badly also - the area continued to grow - it is about the size of a tortilla now on her arm around the injection site.
Arm pain; neck swollen; high blood pressure; chest still tight; body aches everywhere,; blisters in mouth; Fatigued; Headache; swollen lymph nodes in the neck; Shingles on roof of mouth and stomach; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on roof of mouth and stomach), PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure) and CHEST DISCOMFORT (chest still tight) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease in 2001 and Anxiety in 2001. Concurrent medical conditions included Hypothyroidism in 2002 and Blood pressure high in 2001. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METOPROLOL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Jan-2021, the patient experienced HERPES ZOSTER (Shingles on roof of mouth and stomach). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), HYPERTENSION (high blood pressure), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck). At the time of the report, HERPES ZOSTER (Shingles on roof of mouth and stomach) had resolved, PAIN IN EXTREMITY (Arm pain), SWELLING (neck swollen), CHEST DISCOMFORT (chest still tight), PAIN (body aches everywhere,), ORAL MUCOSAL BLISTERING (blisters in mouth), FATIGUE (Fatigued), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph nodes in the neck) outcome was unknown and HYPERTENSION (high blood pressure) had not resolved.            Treatment included anti-viral medicine, famber, for shingles. she was given a second prescription because she got shingles on her stomach   This case was linked to MOD-2021-097373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Medical history, concomitant medications, therapy details and new events were added. Patient age was updated.
Dizzy; Sick to the stomach; Could not eat; Sore throat; Pain in arm; Horrendous headaches; Pass out the day after; Very sick; A spontaneous report was received from consumer concerning female patient of unknown age, who experienced pass out the day after (syncope), very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (vaccination site pain), and sore throat (oropharyngeal pain).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received first dose of two planned doses of mRNA-1273  on 11 Mar 2021 intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021 the patient was very sick.  On 12 Mar 2021 the patient passed out. Patient stated she had horrendous headaches, was dizzy, sick to stomach and could not eat. Patient stated she had pain in arm and sore throat.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, pass out the day after (syncope), was considered as recovered on 12 Mar 2021. The outcome for the events of very sick (illness), horrendous headaches (headache), dizzy (dizziness), sick to the stomach (abdominal discomfort), could not eat (decreased appetite), pain in arm (pain in extremity), and sore throat (oropharyngeal pain) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rash/red streaks developed on different parts of the body (both sides) including chest, stomach, shoulders, legs and to a lesser extent on the arms and back. The site of injection was NOT affected. The streaks looked like red scratches from 1 to 5 inches long with some having small blisters. If not touched, they didn't itch. Other rash appearances were red splotches and small red pin spots. A couple of the places were painful which subsided after taking Advil. No fever was detected. Treatment: Injected with steroid, methylPREDNISolone prescription, triamcinolone.  Day 2: Still have notable redness/streaks but blisters have subsided. No pain experienced.
Numbness on the left side of the face; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 15:00, the patient experienced numbness on the left side of the face. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021, the patient underwent nasal swab test for COVID-19 and the result was unknown. The clinical outcome of the event numbness on the left side of the face was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax & immediately following 2nd inj devel swollen tongue & felt as if were choking; sx subsided p/approx 1/2 hr; lab eval in OCT93;
Hypotonic-hyporesponsive episode within 72 hrs of vaccinations during 2 month well-child exam. Observation inpatient x 48 hrs. Event self resolved after 10 mins without recurrence.
I received my first dose of the COVID vaccine on January 12, 2021.  I had a headache on the night of Jan 15 so took two Tylenol pills.  I woke up with a worse headache so took two Excedrin Migraine pills in the morning.  At about 10 am I started a 10 mile run, which is not unusually long for me.  I finished before noon and when I urinated , it was almost all blood, which has never happened to me before.  I went to the emergency room.  They gave me IV fluids and took some blood tests.  My creatinine levels were abnormally high but the doctor felt I overexerted myself and was too dehydrated even though the workout was not unusually for me.  On January 18th, I developed a quite painful lump in my left armpit, that lasted about a week.  I saw my primary care physician on Jan 23rd for a follow up.  He thought the lump was a swollen lymph node from the vaccine and was not concerned.  He scheduled blood tests and an ultrasound of my kidneys, all of which came back normal. I received my second vaccine shot on Feb 9th.  I developed a headache that night and have had a headache most of the time since.  I have taken several pills of Excedrin Migraine over these few days.  I also traveled to San Diego on the 10th and did a fairly long and arduous hike up a mountain on the 11th.  Although it was intense, it?s the type of hike I do several times a year and not completely out of the ordinary.  I was also a bit dehydrated again.  I woke early morning on the 12th with another headache so I took two more Excedrin MIgraines and went back to bed.  When I awoke about 6am, I urinated blood again.  I urinated blood for several hours and have finally drank enough water to end the blood urination. I normally work out intensely several times a week and do have bouts of dehydration.  But I have never urinated blood before.  I can?t help but believe it?s no coincidence that the two times in my life I?ve urinated blood have coincided with COVID vaccine shots.  Not sure how my exercises, dehydration, and use of NSAIDs  have contributed but something is going on and it needs to be investigated.
Site of injection r arm, scalding, extreme itchiness.  No rash, no swelling , no welt.  R shoulder joint pain
I woke up one morning and I couldn't move the right side of my face I thought I was having a stroke. I went to the ER for treatment where I was diagnosed with Bell's Palsy. I had a CT Scan of my head and brain and I also had bloodwork done. I experienced paralysis on my face.
Information has been received on 19-JUL-2017 regarding a case in litigation regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-DEC-2015, the patient was treated at the Emergency Room for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report received from a medical assistant referring to a patient of unknown age and gender who received a dose of ZOSTAVAX on 14-JUN-20187 (lot# M042854, exp. 18-JAN-2018) for prophylaxis. The medical assistant reported that the patient received the injection of ZOSTAVAX intramuscularly which is outside of the recommendations per prescribing information. No adverse effect was reported. Lot number M042854 has been verified to be a valid lot number for Zoster Vaccine Live.
HPI: The Pt is a 62 year old female who presents with localized injection site swelling immediately after receiving her vaccination. Pt had 1st dose Pfizer to the right deltoid. She denies any pain at the injection site. Pt denies any Hx of allergic reactions or incidence of injection site inflammation in the past. She has a Hx of DDD, carpal tunnel syndrome, and nerve pain for which she takes Cymbalta and Celebrex. Pt also takes oral Prolia for osteoporosis. Pt denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin. She also denies numbness or tingling in the bilateral UEs.
Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 52-years-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI446AA, expiry date: 30 June 2016) intramuscularly in left deltoid on 14 October 2015. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15 October 2015, one day following the vaccination, the patient had developed red, puffy left armpit. Laboratory data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none. Follow up report received from a nurse on 7 January 2016. The patient was recovered from the event (reported as patient was fine and no lumps).
COULDN'T SLEEP; WAS IN SO MUCH PAIN; NECK PAIN; SHOULDER BLADE PAIN; ARM WAS SLIGHTLY SORE; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, 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, the patient experienced couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. This report was non-serious.
Redness, soreness, severe pain in the upper arm, swelling, discomfort and fever for a week, also weakness and a severe lump on the neck area the size of a fist that has lasted now more than 4 weeks. I reported it to the doctor 3 days after who prescribed the medication Prednisone for the purpose.
Information has been received from a nurse practitioner for the Pregnancy Registry for VARIVAX (Oka/Merck) concerning a 26 year old female with asthma who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. On 26-SEP-2008, the patient was vaccinated with a second dose of VARIVAX (Oka/Merck), 0.5 mL, subcutaneously. Concomitant therapy included albuterol as needed. Subsequently, on 27-OCT-2008 a serum pregnancy test was performed and the patient was determined to be pregnant (LMP was in July 2008 and estimated date of delivery is 08-MAR-2009). No problems reported. The patient went to the office. Follow up information was received from the nurse practitioner. It was reported the baby was born on 11-MAR-2009. The patient was induced for pre-eclampsia at term. The patient told the reporter she eventually had a ceasarean. The patient thought it might have been a "failed induction", but the reporter did not have specific. The reporter saw and evaluated the baby for normal newborn jaundice on day 4 (approximately 14-MAR-2009). The baby was otherwise normal and healthy, and had a normal birth weight, though the reporter couldn't recall the exact weight. Upon internal review, "failed induction" for ceasarean was determined to be an other important medical event. No further information was available.
Swelling at injection site upper left deltoid area excess of 24 hours pain on touch.
approx 48 hrs following admin of vax pt devel elevated of 105 R; pt was taken to ER & MD found no other problems; elevated temp lasted for 48 hrs;
The subject was a three month, 22 day old infant female, HIV infected, enrolled in a study, who expired at home on January 04, 2007. The subject received three doses of Prevnar on November 6, 2006, December 4, 2006, and December 28, 2006. At screening, the subject's CD4 count was 1534 cells/mm3 (28.2%) and HIV-1 viral load was > 750,000 copies/ml. On December 28, 2006, during the subject's routine study visit, the investigator found the subject had diaper dermatitis but was otherwise well. The subject was not seen for the next scheduled study visit on January 29, 2007. The site contacted the mother and learned that the subject had died January 4, 2007. According to mother, the subject died as a result of a "chest problem." The mother stated the subject had developed a fever but did not know the exact temperature. The site Principal Investigator stated that the only information available was provided by the mother and that, it is assumed the subject developed pneumonia that resulted in death but no concrete evidence is available to substantiate this. There was no post-mortem examination performed. The site Principal Investigator assessed the relationship as possibly related to the study agent, Prevnar. The DAIDS Medical Officer has deemed the adverse event as probably not related, but cannot rule out relationship to study agent, Prevnar. Concomitant medications included: cotrimoxazole and the subject had also received oral poliovirus vaccine(OPV), hepatitis B and CombAct-HIB vaccines.
Small red rash around Left thigh injection site, was slightly hot and swollen, has now since decreased.