chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After first shot I felt just a little tired and weak.  Took the second shot and within an hour started to feel like my heart was racing then was tired and felt bad for a couple weeks.  Then I had a massive stroke.  Spent almost two months in hospital and rehab facility until insurance ran out.   Over a year later I still have little to no use of my right leg and right arm and hand.  Speech was very difficult but has gotten better.  Currently still trying to rehab with home therapists.
Information has been received from a consumer concerning children who were each vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. It was reported that "the children were fine before receiving the vaccination" but later developed autism. The reporter felt that measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live caused the autism. No further information was available at the time of this report. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
temperature excursion; No additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 26-JUN-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) injection (lot #W029552, expiration date 14-MAR-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis, instead of dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (Wrong vaccine administered, Product storage error).  On unknown dates, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD)suffered from a non supported temperature excursion of 8 degrees Celsius for 2304 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
Injection arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm  soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm  soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Injection arm  soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication taken by the patient included blood pressure medication.     This case was linked to US-MODERNATX, INC.-MOD-2021-095295 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095295:2nd dose
Within an hour of vaccination, a hard red spot appeared at and a little lower from the injection site. It was about 3" and oblong in shape.   6 days after, a rash appeared in random spots: forearm, back of neck/upper shoulder, leg.   Day 7 hives appeared where the red hard spot hard been.
Arm was sore that evening  and later developed (two days later) a raised red area with a slight rash, about 2.5 inches in diameter.  It was slightly itchy.   Lasted for one week.  No treatment was sought.    Also was fatigued for the first 36 hours.
Pt given PPV23 on 10/8/14 and 10/29/14.
Narrative:  Patient experienced symptoms of chills, muscle aches, loss of appetite, and dizziness approximately one week after receiving the first COVID-19 vaccination dose.
Blood pressure began a steady rise over the next several days, up to approximately 160/100.  It was a steady rise from approximately 130/85.  I had not seen a steady rise like this in the past.  It began after the 1st COVID shot (2/26).  I did not connect the increase in blood pressure to the vaccine. because it was not listed as a side affect. The trend is evident on a plot of daily blood pressure over. I contacted my PCP when the BP was not returning to normal.  PCP added 2.5mg Amlodipine Besylate to medications (5/12).  This did not have an affect.  My Nephrologist increased my Ramipril dosage from 15mg to 20mg (5/20).  My BP began to return to normal (beginning of June). No special tests or hospitalization.
Sore arm, itchy, red lump under skin where injection was given,  lower back pain
Persistent fever 103.5 - 103.7 (2 days), nausea, vomiting, body aches, headache, chest pain
This spontaneous report was received from a pharmacist  via a company representative, referring to a female patient in her 60's. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose number, dose, frequency, administration route, lot number and expiration date were not reported) for prophylaxis.  Concomitant therapies included sterile diluent (lot number and expiration date were not reported). Pharmacist reported that on an unspecified date after receiving ZOSTAVAX, the patient returned to the pharmacy with a case of shingles (herpes zoster). It was also stated that the patient was upset about it (feeling abnormal). The outcome of herpes zoster and feeling abnormal was unknown. The causality assessment between ZOSTAVAX and the aforementioned events was not reported.
Fever, Chills, Shaking(shivering), hemolysis(PNH) exacerbated (hemoglobin dropped from 11.1 to ~9.0)
Minutes after the vaccine I got a tingling sensation on my skin that moved around all over my body. This lasted about 30 minutes. My arm, at the injection site, was very sore for 2-3 days after. On 1/08/21 I noted a small red spot at the injection site that I thought was a bruise; however, on the evening of 01/09/21 I noticed it had grown to approximately 3 inches in diameter. It was red, a little swollen and a little itchy.
anxiety disorder; anxiety disorder; Fatigue (extreme)/ worn down; chills (shaking); nausea; tightness in his chest; lightheaded; no appetite; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The relevant medical history included anxiety disorder from an unspecified date. Concomitant medications were not reported. The patient wanted to know if he could delay the second dose, due to his anxiety around receiving it. He was calling to report an adverse reaction to the first vaccine and he was nervous about getting the second one. How much coverage after the first one, necessary to get the second dose. After the first one he was worn down for about 5 days, had an anxiety disorder as well. Fatigue (extreme) and chills (shaking) some nausea. Right away he felt some tightness in his chest and felt really lightheaded, they gave him gatorade and it helped. No appetite, tested for Covid, etc. He thought he might have corona-virus was tested and was negative. He also reported a history of anxiety disorder which may be contributing to his hesitancy around the second dose. The patient got a negative antibody test after being vaccinated. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right arm is kind of swollen in two places and a rash; Right arm is kind of swollen in two places and a rash/ bad rash; Had a really bad effect of not being able to breathe while I was sleeping, but it was so bad that I could hear myself gasping for breath; Have little bit of nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 07Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included patient received first dose of BNT162B2 received for Covid-19 immunization and experienced little mild imbalance (it went away). Concern: Consumer stated, "This was the number they gave me to report a possible side effect, this was my second corona vaccine shot (COVID Vaccine), I got on Monday. I did not had any problem with the first one, except for little mild imbalance and then it went away, but with the second one I got Monday, I have seen to have a really bad rash, my right arm was kind of swollen in two places and a rash, I had a really bad, just you can say effect of not being able to breathe while I was sleeping, but it was so bad that I could hear myself gasping for breath when I woke up. And when I woke up I also felt nauseated, I have little bit of nausea now but that's about it. So patient wanted to know were those effects something that will kind of go away or there was something that patient need to go back to where patient got the shot or the doctor". Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information was the right department who can answer the questions which consumer have. When offered the number for Pfizer Medical information consumer stated, "You know what maybe I will just call them back and see what they say." and hung up the call abruptly. Further information could not be probed as the consumer hung up the call abruptly. Hence limited information available over the call. The outcome of the event have little bit of nausea was not recovered and outcome of other events was unknown.  Information on the lot/batch number has been requested
Patient admitted through ED for shortness of breath, cough, malaise, had tested positive for COVID 6 days prior and had received monoclonal antibody infusion as outpatient.
COVID-19 Treatment; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 30 minutes of receiving the influenza vaccination, the associate experienced intense itching followed by a progressive non raised red rash resembling a drug reaction. This involved the upper right arm, posterior shoulder and right chest. The injection site was swollen and warm to touch as well. The associate was seen in the Occ Health clinic and treated with Benadryl. This was diagnosed as a local reaction. There was no breathing difficulties or other reactions involved.
Breakthrough case admission after two vaccines  Pfizer 3/1/21 Lot# EN6200;  Pfizer 3/22/21 Lot# EN6206
Severe pain R arm & shoulder - non focal bed movements & stiffness R shoulder.  No tenderness/redness over injection site.  Treated with NSAIDS.  Recovered gradually over 2 weeks.
Patient received flu shot and proceeded to go in line to hand paperwork to RPh to sign. While in line patient fainted, was passed out for no more than a minute. Patient reported no adverse reactions and no other injuries. Campus police was called.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the second lasting for 12 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit (9 degrees Celsius), the third lasting for 24 hours, with highest recorded temperature of 48.1 degrees Fahrenheit (8.944444444 degrees Celsius), the fourth lasting 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the fifth lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the sixth lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the seventh lasting for 24 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit (7.944444444 degrees Celsius), the eighth lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius) and the ninth lasting 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Medical history, concurrent condition and concomitant therapy were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M005714, expiration date 03-OCT-2017, for prophylaxis (strength, frequency, dose, route and lot/batch number were not reported). The vaccine was exposed to temperature of 34.3 F, during 4 hours and 18 minutes. The call was because of data logger. No previous temperature excursions and no adverse effects were reported.  There was no Product Quality Complaint (PQC). Additional information has been requested.
Patient received vaccination on 9/14/2011. Started having symptoms about "4-6 weeks" after vaccination. Signs and symptoms: general weakness of hands and feet; hands started to tingle and became numb, patient stated that it "felt like a glove pushing all the blood out of his hands"; left forearm, shoulder and left thigh started having sudden sharp pain. Went to ER, kept him there for 5 ½ days and was diagnosed with GBS. When patient's wife called to report event he was still having general weakness of entire body, cold hands and a feeling of being constantly run down, needs a cane to get around.
Although I had two initial Pfizer vaccinations, one Pfizer booster and one Moderna booster, I still caught COVID-19. I did not have a bad cough or fever, but I was dizzy, extremely fatigued, had a bad headache and developed severe lower back pain. I took Paxlovid for five days and was generally better after that, but my lower back pain has continued.
Information has been received from a physician concerning his 20 year old female daughter with no other pertinent medical history reported. On 18-JAN-2007, the patient was vaccinated IM with the first 0.5 ml dose of Gardasil (yeast). There were no concomitant medications reported. On 28-JAN-2007, the patient developed unilateral supraclavicular lympadenopathy. There were no other symptoms reported. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Fever of 102 degrees F started 24 hours after administration and continued for 4 days after administration.  There was also associated anorexia and fatigue. 48 hours after administration, patient developed a cough that was productive.  Examination of pt revealed pyrexia and fatigue but no ENT or Lung abnormalities.
On 2/6/06, MD evaluated child for right leg pain with tenderness at injection site. Diagnosed with cellulitis on right leg secondary to injection. Augmentin 600mg BID prescribed.
just getting over them/ I got them; pain; pain in my leg; pain in lower back; pain in knee; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pain, leg pain, low back pain and knee pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain, leg pain, low back pain and knee pain were recovered/resolved.   It was unknown if the reporter considered the shingles, pain, leg pain, low back pain and knee pain to be related to Shingles vaccine.  Additional details were provided as follows: This patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced shingles and worst pain of his/her life for 14 days. The patient's doctor said its a virus that enters and lands on a nerve, so he/she had so much pain in his/her leg ,lower back and knee. The patient stated that he/she never want this agian and he/she could get it agian he/she was told so please get your shingles vaccine. The patient was waiting for his/her next dose. The follow-up would not possible as no contact details were available.
40 minutes later, I became flushed, hot, sweaty and clammy and tachycardic along with a syncope episode. Nausea came after, and only treatment was fluids. This episode happened after discharge around 9:45pm and then returned to the hospital for the same course of action.
Intense nausea; Ringing in ears; This is a spontaneous report from contactable consumer. A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0162, expiry date: unknown) via unknown route of administration on 09Apr2021 at 16:10 as 0.3ml, single dose for COVID-19 immunization. Patient's medical history included hypersensitive esophagus (Feb2020), diabetes, Parkinson's, Lupus nephritis, Leukemia (Dec2000). For hypersensitive esophagus the patient took Amitriptyline 10mg, start date: Apr2020- ongoing, Nexium 20mg (1 per day), Start date: Mar2020, ongoing. The patient underwent lab test for blood test which was normal, covid-19 as negative, and endoscopy on 12Mar2020 that was not too bad; patient's gastro doctor told her it looked like some kind of virus infected me possible covid? he said other than that it didn't look too bad. Concomitant medications included Multi, vit c, vit D 2000, Calcium, on and off for 2 to 3 years ongoing, Levothyroxine 50ml for Underactived thyroid, start date: Taken for 10 to 15 years- ongoing. After vaccination, the patient experienced, In-tense nausea and Ringing in ears on 10Apr2021 at 14: 00. The outcome of event was recovered approximately on 20Apr2021 without treatment.   No follow-up attempts are needed. No further information is expected.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 10-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Patient was given a Pfizer covid bivalent dose that was 10mcg 5-11 age group instead of the 30 mcg 12+ age group.
Less than 24 hrs later, Pneumovax site developed redness, hardness with slight edema and slightly raised, 2cmx1 1/2 cm, polio site same with measurement of 1cm x 1cm. Child spiked a fever, T max 101.8, Elevated heart rate of 160's-150's, As of this report 4/22/05, 1600, child is recovering.
Arm started hurting after 10 minutes, area red around bandaid and in bilateral antecubital spaces. No swelling or heat. Also reported blurred vision.  Reports being in the sun on Sunday.  No shortness of breath, nor throat swelling or anyother symptoms.  b/p 130/78  pulse 64. 9:35 Hive type rednness in bilateral axillary.   9:40 reports no further blurred vision. Has appointment with Dermatology & Pulmonolgy.  Pictures taken to show dermatologist.
Pt stated she felt like she had to throw up then began feeling faint. Pt then threw up x1. Staff elevated feet, put head up, applied cool/wet towel. Temp 96.8. Pt reports not eating before taking vaccine. Offered water and food. Refused food. Drank 8oz water. Stated she felt better after throwing up. No further complaints of nausea or faintness. Able to stand and walk in own and appropriately. Mother present. Pt left with mother after observation period over.
On May 27, 2022 in the evening, I started with a scratchy throat that turned into a very sore throat, high fever, headache. I was given Paxlovid which I took May 28, finished the full dose and felt better within 48 hours. June 11, I started to get very tired.  June 12, we flew home and my ears were bothering me so I took a COVID-19 test and tested positive again.  I had a lot of nasal congestion, tiredness, scratchy throat.  3-5 days later, the symptoms began to subside, with the help of Flonase, Tylenol and Advil and stayed in bed.
Nurse observed that the patient had a scar on the left arm and patient stated that scar is from multiple vaccines. Patient advised to get vaccine on right arm instead and patient stated that he wanted vaccine on left arm because he gets all his vaccines in that arm.  Nurse proceeded to give vaccine and inject into muscle, but under the scar. As nurse pushed in the vaccine, some of the medication came out of the puncture site. Amount patient received is unknown. Did not redose.