chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning a 30 year old white wife who on 7/2/00 was vaccinated with 1 dose of varicella virus vaccine live (site unknown). On 9/6/00, it was confirmed that she is 9 1/2 weeks pregnant (LMP: 7/5/00). Follow-up information from the consumer noted that the pt had the baby on 4/8/01. Additional information received from the consumer noted that the pt had been tested for varicella antibodies before vaccination in 2000 and the results were negative. In approx. 9/00, the pt developed nausea and was started on therapy with metoclopramide hydrochloride (Reglan) 10mg, the number of doses taken was noted to be "at first 5 and then 2". The metoclopramide hydrochloride (Reglan) was stopped on 4/8/01. On an unknown date, the pt had a positive test for alpha fetoprotein. At "around 20 weeks" the pt had the amniocentesis done that was normal. The amniocentesis was performed because the pt had the positive alpha fetoprotein test and then had the test retaken and had a negative test result. It was noted that the pt delivered pre-term at less than 37 weeks gestation on 4/8/01, a normal male weighing 4 lbs and 11.6 oz. The pt did not have any complications during labor/delivery and there were no concurrent medical conditions. The pt did not have a local reaction at the vaccination site and there were no symptoms of varicella or herpes zoster. Follow-up information from the pt's medical records noted that the pt was hospitalized twice for hyperemesis and treatment with unspecified medications (dates not specified). The pt's LMP was noted to be 7/23/00 (previously reported as 7/5/00) with an EDD of 4/30/01. On 2/26/01 and 3/12/01 it was noted that the pt was "doing well". It was noted on an unspecified date, that the pt was to start "NST" regarding an increased alpha fetoprotein test early in pregnancy. No further information is available. A follow up report received 12/27/2001 adds: Follow-up info from an office manager in a physician's office stated that their records do not indicate that the pt received (varicella virus vaccine live) under their care but it had been reported by another physician earlier in the pregnancy as the pt transferred to this office late in the pregnancy. It was confirmed that the hyperemesis had resolved as the pt had delivered. No further info is available.
Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
fever of 100.1 up to 102.3  within 11 hours of being vaccinated, nausea, chills, aches and pains, headache. This lasted for 24 hours then symptoms ceased to exist.
Information has been received from a physician concerning an 11 year old female who on unspecified date, was vaccinated with a first and second (SQ, booster) dose of Varivax. Concomitant vaccinations included, the first dose of Vaqta generic (manufacturer unknown). Subsequently, "two weeks post vaccination", the vaccinating physicians office referred the patient to the specialist physician as the patient developed "long horasic (or thoracic) nerve palsy with scapular winging". Unspecified medical attention was sought. No product quality complaint was involved. The patients' adverse events were considered to be other important medical events. Additional information has been requested.
Cold sore outbreak beginning Sunday the 22nd and still continuing on August 31. Some are healing and new are showing up. I did have a 102° fever Friday. Sometimes fever and stress trigger a cold sore but this outbreak is the worst I?ve ever had.
Very swollen and painful lymph nodes all over entire body (chest, shoulders, arms, stomach, calves) for 1 week. Felt nauseous, dizzy, and exhausted. No appetite. Struggled to read and process things. Could not work. Sharp pains in lymph nodes at various times throughout the day. Chest felt very tight and arm hurt to the point I thought I might be having a heart attack. Had trouble sleeping due to lymph node pain. Ibuprofen did not help. The arm pain at injection site was annoying but I barely noticed it due to my other symptoms.
Hives at site of injection at 10:48 am, both MMR and Varicella. BENADRYL 10 mg given in office at 10:50 am.
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
second period two weeks after the second dose; headache; sore arm; slight temperature; tiredness; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received second dose of BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 03:45 (Batch/Lot Number: ER8734) as 2ND DOSE SINGLE for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, The patient has not been tested for COVID-19 since the vaccination. The patient experienced second period two weeks after the second dose, headache, sore arm, slight temperature and tiredness all on Apr2021. No treatment was received for all the events. The outcome of second period two weeks after the second dose was unknown. Outcome of all the other events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
The pt experienced a red, raised bump slightly larger than a quarter on the left leg with leg pain, that is getting worse in past 24 hours on day 7 post vax. Instructed to be evaluated by pediatrician. Pediatrician described a normal mild reaction. No treatment required.
Blood in diaper, took diaper and child to clinic, Dr immediately identified source as rotavirus vaccine, told us not to get next rotavirus vaccine and prescribed probiotics.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ (strength: 2ml) (dose and frequency were not reported). No adverse effect reported. It was also reported that the product was back in proper storage at the time of call. It was also reported that there was a previous excursion for same product. Yes 1st excursion 48F for 5.5 hours 2nd excursion 56F for 28 hours 3rd excursion 61 F for 64 hours was it administered. The temperature range was 61 F and time frame was total cumulative time 97.5 hours. No further information was provided. This case is linked to the case 1404USA014696 and 1404USA014697 (same reporter link). Additional information is not expected.
Throat felt tight when I swallowed. Chills, severe headache, body aches, muscle weakness,  menstral cramps (without menses), nausea, loss of appetite. Rash on roof of mouth.
the patient wanted to get the "booster" of MMR II and VARIVAX but received PROQUAD on 7/13/2022 instead; a 31 year old patient received PROQUAD instead of MMR II and VARIVAX; patient's recent titer test for MMR and varicella came back "low level"; patient's recent titer test for MMR and varicella came back "low level"; Mumps antibody test negative; patient's recent titer test for MMR and varicella came back "low level"; This spontaneous report has been received from an office manager, regarding a 31-year-old male patient. The patient's concurrent and historical conditions, drug reactions/allergies and concomitant medications were reported as none.   On an unspecified date (in the past), the patient had received varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date, dose, site and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, site and route of administration were not provided) for prophylaxis.  However, the patient's recent titer tests for measles, mumps, and rubella (MMR) and varicella came back "low level" (measles antibody negative, mumps antibody test negative, rubella antibody negative, antibody test negative), so the patient wanted to get the "booster" of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).    But on 13-JUL-2022, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live (PROQUAD) 1 dose, (lot number# U014798, expiration date: 06-NOV-2022) (dose, site, and route of administration were not provided) (product administered to patient of inappropriate age) instead (wrong product administered). No additional adverse events (AEs) were reported. These events were no cancer, overdose, hospitalized or prolonged, life-threatening, significant disability, or intervention to prevent serious criteria. No further information was provided.   The outcome of these events was not reported. The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between the events and measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live (PROQUAD) was not related.
Systemic: Allergic: Anaphylaxis-Severe, Additional Details: patient called 6/14 after being notified that she was due for second dose to report she had anaphylactic reaction after first dose and would not be getting second dose. Patient did not experience anaphylactic reaction during observation period after the vaccine so unsure of timing of the reaction
The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial did not undergo any temperature excursions. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. The Pharmacist does not have any other adverse events or side effects to report. No treatment medication information was provided.
Right deltoid area had redness and slight swelling, warm to touch, but not hot. Mother reported first noticed today 7/28/04. Patient reported areas itched.
04/18/2022 Vaccination; 04/19/2022 I woke up, I had a temperature of 101.0. I hurt, joints and muscles all over. I had a HA, very lethargic, barely able to stand up. I went in and out of sleep all day, barely ate, nauseated, throwing up. 04/20/2022 Symptoms were worse. I was very disorientated, very out of it. 04/21/2022 I made myself go to work. I was able to take a little bit of water and food in. *72 hours from shot, experienced symptoms. COVID.
4 hours after shot broke out with many hive and welts progressed thru next 4 mn with welts and hives on various parts of body. Slow to heal lasting > 1 wk. Saw UC, primary, and allergist. Dx serum sickness-like rx.
No additional AEs were reported; The healthcare worker reported that 1 patients received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous information has been received from an other health care professional concerning to a patient of unknown age and gender.   The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 18-APR-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U015476, has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and validated as 13-NOV-2022) (strength, route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional adverse events were reported (no adverse event). No previous temperature excursion was reported.  This is one of 14 reports from the same reporter.
Patient presented back at work with a rash on her chest, mouth felt tingly, had red blotches on her arm about an hour after receiving injection. Patient returned to ER and was given Benadryl and monitored for 3.5 hours.
20 minutes after receiving vaccination, tingling tongue. 'first sign for shellfish reaction', noticed tongue swelling. took 2 benadryl  @130.  at 1:45 took Albuterol, got to hospital / ER at approximately 2pm.  Elevated BP, HR increase, lungs tight and 'barely diminished'.  Epi @ 4:25 Albuteral @ 4:35 Prednisone @454 IV pepcid @5pm Tongue was still swollen but improved, lungs stable. Discharged at 6:10.  Continued Benadryl and med pack.  F/up appt w/ Allergist the following week;
1st dose no bad reaction or side effects. 2nd dose  at 4pm on 2/2/21  At 5am on 2/3/21 woke up to very sore arm and very high fever, achy, chills and could not get out of bed all day. Temp at it?s highest 103.7 at around 1pm. I took Tylenol and Ibuprofen alternating every 4 hours and that kept my temperature  at about 100-101 all day.  Injection site is swollen, hot, and very sore. It is 9 pm on /3/21 and took Tylenol last at 8pm and temperature in 101.7.
MMR vaccine was given on 3/9/21 and the expiration date was 2/27/21
Around 2 weeks later patient suffered severe migraine and vomiting. This has now occurred 3 more times since the first. Patient never did suffer from headaches/migraines beforehand. Each time the migraine happens, patient's complexion turns white, left hand goes a little numb and then she throws up and sleeps the rest of the day. This all usually happens around 9am when she's at school.
Headache and fatigue. Later that night his upper left jaw started hurting up to his ear. As he was opening and closing his jaw he stated he heard a grinding. It got worse and he couldn't open his mouth. He has to keep his mouth at a relaxed position to talk. He can't bite down as of now so, he can not chew food at this moment.
Case number PHEH2014US014430 is an initial spontaneous report from a consumer received on 09 Jul 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in Oct 2013. On the same day, within one hour after vaccination, she started getting shortness of breath that lasted about one hour. Then her blood pressure and pulse were elevated and indicated irregular heartbeat. About three hours after getting the flu shot this stopped. Seriousness and causality of the events were not reported.
About 5 minutes after injection I had a wave of dizziness and hot flash which only lasted a few seconds.  I remained at the facility to make sure I was OK to drive.  Later that evening until next day at noon I was slightly dizzy.
No other AE reported; it was given past its expiration date; We read the date incorrectly as it is printed on the bottle as 2020 Sept 22; This spontaneous report was received from a registered nurse referring to an 11-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 29-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, lot # N032284, expiration date 22-SEP-2020) for prophylaxis, the registered nurse read the expiration date incorrectly as it was printed on the bottle as 2020 Sept 22, so thought the year was 2022, which past its expiration date (expired product administered and product expiration date issue). No other adverse event was reported.
2-3 weeks after receiving a second varicella vaccine, I broke out in a full body rash that appeared identical to one associated with varicella infection. The rash persisted for several days. I did not experience pruritis at any time.
headaches in frontal part of head; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), 1st dose on 01Mar2021 at 11:45 am, solution for injection via an unspecified route of administration in the left arm for Covid 19 immunisation (at the age of 38 years). Medical history included daily headaches and neck pain for unknown reasons. The patient also gets Botox for daily headaches every 3 months. The patient had allergies to Topamax (MANUFACTURER UNKNOWN) and Pictocin (MANUFACTURER UNKNOWN). Concomitant medications included T3 (MANUFACTURER UNKNOWN), Skelaxin (MANUFACTURER UNKNOWN), amitriptylin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and prega (MANUFACTURER UNKNOWN for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 02Mar2021 at 09:00 am, the patient experienced continuing headaches in frontal part of head in high forehead and left eye daily headaches. The ache was not debilitating, but nagging. That was new from the daily headaches which tend to occur in occipital area and temporal area. The patient has not recovered from the event of headaches in frontal part of head at the time of reporting. Information about lot number cannot be obtained. No further information is expected.
Pyrexia/Fever; Rhinorrhea/Runny Nose; Cough/Dry cough; Rigors/chills; Pain/Generalized Aching. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 36 year old female patient who experienced runny nose, dry cough, chils, body aches and fever. At 36 years of age, th patient received a dose on 12-Dec-2003/ The patient experienced runny nose (rhinorrhea), dry cough/cough, chills/rigors and body aches/pain on 13-Dec-2003. On 17-Dec-2003, she developed a fever (pyrexia) of 100.7 deg F. No additional information was available at the time of this report.
They got appointments for 4 weeks later; This case has been considered invalid as there is no indication that the patient experienced an event under suspect product BNT162B2.  This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), via an unspecified route of administration on an unspecified date and time at single dose for covid-19 immunisation. Medical history included none. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 25Jan2021. Concomitant medications were not reported. The patient reported, they got their first shot on 25Jan2021. She heard the vaccine was supposed to be given 3 weeks later, but they got appointments for 4 weeks later. The seriousness was reported as non-serious. The outcome of the events unknown.  Information on the lot/batch number has been requested.  Amendment: This follow up is being submitted to amend the previous reported information which included: to make the case invalid as patient's schedule is within the 19-42 days range after the first dose (hence not an event).