chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they do not work; they do not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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), COVID-19 (medically significant), outcome "unknown" and all described as "they do not work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke with body aches,102.6 fever,horrible headache. Lasted the whole day after injection. Around 5:30 pm I started feeling whoozy and passed out. Neighbor couldn't bring me around. 911 was called. I started vomiting and very nauseous by 6:00 pm. All vitals were ok by medics. I went in my house,went to sleep and woke the next day fine. Wasn't sure about the passing out and vomiting, nor the fever for the day being normal.
Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on the right arm on 22Mar2021 at 03:45 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ascending aortic aneurysm. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to 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 4 weeks prior to the COVID vaccine. On 22Mar2021 at 03:45, the patient experienced ringing in ears, stiff neck, swollen lymph nodes and distracting. The patient also reported that ringing started 3 minutes after getting shot and it was distracting her. No therapeutic measures were taken as the result of reported adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome ringing in ears, stiff neck, swollen lymph nodes and distracting were unknown.    No follow-up attempts are needed. No further information is expected.
Patient began exhibiting injection site redness, swelling, and warmth that was discovered approximately 6 hours post administration.   At approximately 0245 on 26JAN2020, patient awoke crying and vomited twice within 30-45 minute period.
Pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 or 68 years. The field representative reported the adverse event by a nurse. The patient experienced pain with the first dose of Shingrix.  No further details were provided. The case was linked with the case US2019169171, reported by same reporter for same patient.
Arm hurt; chills; vomiting; headache; Can't keep anything down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Fibromyalgia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache) and DISCOMFORT (Can't keep anything down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported Treatment information   reported was Tylenol  Arm hurt initially. Then at night woke up with chills, then was vomiting and is still vomiting. Can't keep anything down. Also has a headache. Caller vomited while on the call
Pt recieved smallpox vaccine 10/04/12. Looked normal when it was checked 10/11/12. 10/14/12 pt noticed raised red streaks coming from vaccine site. Upon inspection by vaccine administrator noticed abnormal swelling on 10/15/2012 along with secondary lesion emitting fluid. Pt claims she felt extremely tired. Pt has taken Motrin.
Received seasonal influenza vaccine and developed itching and rash on body, throat started to fell scratchy, cough, became hoarse became difficult to swallow and breathe. Went to be seen in ER and was treated
Swollen arm; sore arm; tiredness and some fatigue feeling in my upper back; tiredness and some fatigue feeling in my upper back; This is a spontaneous report from a contactable consumer reported for self. This 36-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL9262) at single dose in right arm on 20Jan2021 at 03:15 PM for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced swollen arm, sore arm, tiredness and some fatigue feeling in her upper back on 21Jan2021. There was no treatment received for the adverse events. Serious was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of events was resolving.
Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a patient of unknown age and gender was inoculated (by an unspecified person) with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 16-AUG-2011, at a family medicine facility, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 29-MAY-2012, the patient was treated at the same family medicine facility, for a blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Case previously recorded as MA2009-3158. Initial case report received from a consumer via MedCom on 19 OCT 2009. A number of patients of unknown gender and age were vaccinated with S-OIV FLUVIRIN (batch no. 1007391P). The caller stated that Novartis H1N1 vaccine (pre-filled syringes) had reached 32 F while being transported in a cooler with ice packs on 16 OCT 2009. It was unknown whether or not the vaccine had frozen. The vaccine was subsequently administered. The number of patients affected, as well as their age, were unknown at time of report. No adverse events were reported. Reference number: NA09-006491.
Rapid heart rate (resting heart rate went from 55 to 90) lasted for several months Menstruation cycle went from 28 days to 18 with weeks of breakthrough bleeding and extreme symptoms immediately following second shot.
extreme pain, could not lift or move arm, swelling and a hard lump that moved slowly  down my entire arm. Headache, dry mouth Painful to touch. Fatigue for 3 days.
approximately 15 minutes after receiving the covid vaccine pt c/o lightheadedness, itchy throat, which progressed to numb lower lip and then numb upper lip extending to lower nose
12/09/2021- ARM PAIN AT INJECTION SITE AND A FEVER OF 101 DEGREES FAHRENHEIT 12/10/2021- EXTREME JOINT AND MUSCLE PAIN THROUGHOUT THE BODY AND A HIGH TEMPERATURE OF 103 DEGREES FAHRENHEIT. 12/11/2021- SWOLLEN ARM TO THE ELBOW AND SCAPULA PAIN, EXTREME VERTIGO, JOINT PAIN THROUGHOUT THE BODY, AND SEVERE HEADACHE AND FATIGUE.
12/31, 08:30pm: Immediate pain & welt developed at sight  12/31, 08:45pm: Slight numbness & tingling in left hand, persisted approximately 12 hours  12/31, 09:30pm (the following s/s persisted in varying degrees until 01/02): exhaustion/fatigue, headache, dizziness, nausea, chills 01/02, 08:30am: chills/cold sweat/fever (temp not confirmed, as my home thermometer had died, but I woke up later that night drenched in sweat as though a fever had broken, and since then my body temp has been normal (no cold chills or hot flashes) and other s/s have also decreased significantly)  01/03: minimal s/s - lingering fatigue, mild  01/04: 03:00a: woke up with cough - uncertain if related (seasonal allergies?)
Patient started to feel nauseous and lightheaded.  He said he also had ringing in ears. He looked pale and muscles in arms were tensed up. I advised he keep his head down and keep breathing. 911 was called when he said his muscles were tensing up. However in the middle of the call he said he was starting to feel better and for the EMT not to come out. He sat down for another 20 mins and left cause he said he was much better and did not have the symptoms anymore.
Conjunctivitis in my left eye, noticed first thing this morning when I woke up, however, I started feeling soreness in my eye last night (approximately 9pm), but no redness until this morning.  Yesterday, the first day after the vaccine, I had extreme nausea and diarrhea, though that seemed normal so I didn?t report it.
No additional AE; inadvertent administration of expired PNEUMOVAX 23 to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-AUG-2023, the patient was vaccinated inadvertently with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #U034712, expiration date: 30-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).  There were no adverse events reported (no adverse event).
A bruise at the injection site; she thinks of vaccine being administered in the blood stream and not in to the muscle; While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein; Gusting blood from the injection site after the administration of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine), VACCINATION SITE BRUISING (A bruise at the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein). On 21-Sep-2021, the patient experienced VACCINATION SITE BRUISING (A bruise at the injection site). On 20-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine) and VACCINATION SITE BRUISING (A bruise at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not on any blood thinners, including Aspirin and Ibuprofen.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
One week after first vaccination a lump about the size of a lemon developed at injection site as well as extreme itching.
Head ache, muscle aches, eyes were aching, chills, sweats, exhausted, tired, low grade temperature 100.4
she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: Patient was suggested that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.  Patient informed of adverse event and states he's 'feeing fine'.
Patient received flu vaccination and while seated passed out.  The event lasted only a few seconds and did not require any emergency measures.  Patient remained seated for about 20 minutes following the event and then was able to walk out of the store with her parent.  Pharmacist called later in the evening to follow up and mother stated that the patient was doing well.
This spontaneous report as received from female registered nurse practitioner of unknown age referring to her. No medical history was reported. It was reported that a years ago patient received a 3 dose of series RECOMBIVAX HB (dosage, route of administration and lot#batch# number were not provided). Subsequently after the vaccination her hepatitis B titer was found negative. On an unknown date of 1997 she had another dose of Hepatitis B vaccine (manufacturer unknown) and a titer following vaccination was negative. It is not reported about the patients sought medical attention. The outcome of titer following the vaccination was negative was reported as not recovered/not resolved. Additional information has been requested.
1/19/2021 heavy arm sore injection sight for 24 hours 2/13/2021 Shingles
I received the booster about 10 am. That night I experienced restlessness and chills. The day after, I had a general sense of feeling unwell and nausea, as well as injection site soreness. In the week since I received the booster, I have had a pounding headache 3 days upon waking, and one during the day. I usually only experience a few headaches a year so this is out of the ordinary. I have been able to control these with 1000 mg Tylenol and have not sought any other medical treatment.
Fever, chills and fatigue the first 3 days,  N/Muscle pain the 4th day.  Migraine the 5th day.
pt recvd vax 29MAR93 & on 31MAR93 devel a rash, fever & flu-like sx; No further details were provided;
Extremely painful injection site lasting about 24 hours, so painful a sheet touching it at night caused pain.  Extreme fatigue beginning  after , increasing in for over 24 hours.
Vaccine administration schedule is outside of the recommended schedule located in the prescribing information; This spontaneous report was received from a pharmacist referring to a 21 years old female patient. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 07-SEP-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot # and expiration date were not reported).  On 06-JAN-2022, the patient came for her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot # and expiration date were unknown). The vaccine administration schedule was outside of the recommended schedule located in the prescribing information (inappropriate schedule of product administration).
Red, swollen, itchy, rash. Took pictures. Started two days after injection. Lasted for about seven days. Also had the pneumococcal vaccine in the same arm.  When I went for the second injection they thought it might have been because I had two shots in the same arm. This time I only had the one in the right arm on February 4th, 2023, two days later, a rash has started.
This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a infant male patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter's grandson got a flu shot when he was about 11 months and had some stuff sounded like a whooping cough. The reporter did not get any suggest from physicians as far as medication. The physician suggested to just eat right, exercise and feed kids healthy foods.
Following MMR had URI symptom including N/V/D. Evaluation on 24AUG90 showed abd soft with mild generalized tenderness. GI liver enlargement noted. 1cm below ribs.
Swelling and itching of the skin next to the injection site initially with pain in this area in the following hours and swelling extending from the left deltoid distally to the left elbow.
Initial unsolicited case received from a health care professional (Medical assistant) on 28 Sep 2016. This case involves a 6 year old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number: U5630AA, expiry date: 30 Jun 2017) intramuscularly in right deltoid on 26 Sep 2016. The patient illness at the time of vaccination was reported as none. And Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no know allergies and any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 26 Sep 2016, one hour after vaccination the patient developed full body hives. The patient was taken to Emergency Room (facility unknown). On same day the patient had fever and low oxygen at ER. The patient's lab tests were not reported. The patient had corrective treatment with Benadryl. The outcome of the events was reported as unknown. List of documents held by the sender: none.
I felt like I had the flu and it was really bad. I was pretty over it after 24 hours. I did not take any medications because I typically don't.
Has there ever been reported of a question about memory loss.  While I am 83  I have experience  three occurrences of forgetting something that i found that I had done. In the last two weeks.  This is new to me.  Just checking
Narrative: COVID infection following COVID vaccine series 04/12, Pfizer, dose #1 05/03, Pfizer, dose #2 08/17 pt cc: cough., fatigue, headache, fever, rhinorrhea, loss of taste or smell exposure: unknown 08/18 COVID swab, result: detected 08/18 SARS-COV-2 Variant Sequencing result: pending.