chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer-BioNTech COVID-19 Vaccine last week (in Dec2020). She claimed being diagnosed with shingles and has asked the nurse if it could be related to the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Delayed onset urticaria and facial paresthesia, lasting for several weeks and responsive to oral prednisone.
Patient  felt he was about to faint , hyperventilated , complaints of shortness of breath , cold clammy skin after the shot
Severe shaking and chills began around 9 hours after injection. I was unable to sleep the entire night. Shaking subsided after approximately 12 hours after it began (around 7 AM on 8/25/2018).  I felt generally ill and headache for approximately 2 days. There was soreness in the arm, but that was manageable. I was "out of action" for two days, and the symptoms were, by far, the worst I ever experienced. I debated about having the second dose, but went ahead with it earlier today (5 months and 1 week after the first dose.)  This time I know what to expect.
fever blister; swollen lymph nodes; injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. Approximately on unspecified date in Apr2021 (After receiving the vaccine), the patient experienced a fever blister, swollen lymph nodes and injection site soreness. Caller stated that she called to report these symptoms and stated: "I've had covid before and want to take every precaution possible". Should she get the second dose of the vaccine. The clinical outcome of the events was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
same thing in their back/back started itching; their back broke up all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over). At the time of the report, PRURITUS (same thing in their back/back started itching) and RASH (their back broke up all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  The patient had the same thing in their back and took Moderna   This case was linked to MOD-2021-406198, MOD-2021-406143 (Patient Link).
Possible reaction to vaccine 1-2 days after administration.  Nauseous, dizziness, headache, ringing in the ears.  Was exposed to grand children just prior to vaccine who were very ill with the flu - like symptoms.  Comes and goes - lasts for 15 minutes.
Severe arm pain, joint pain, mild nausea, severe flu symptoms, chills fever and weakness and sinus drainage
Within 24 hrs. of vax., had redness and swelling in both thighs, (L) > (R). Had increased swelling x 48 hrs., then receded and resolved, without treatment.
Skin turned red around eyes. External body temp was high. Didn't respond to shaking till the 3rd time. When she woke eyes where dilated. She was unaware of things for a few moments. This all happened 15-20 mins after shots were given.
Hypersensitivity reaction at injection site. Patient went to er due to skin reaction. Pt received prophylactic antibiotics to prevent skin infection.
An approximate 3 inch wide palpable mass with redness and warmth. It still is red today, but the mass has dissipated.
Given Pfizer Bivalent vaccine instead of primary series first dose Monovalent Pfizer Vaccine. She had not received her primary series and told the pharmacy this and they gave the Bivalent stating it covers the monovalent and no primary series needed.
Migraine headache, severe.  Associated nausea, vomiting, light and sound sensitivity.
patient complained of sharp pain from left inner ear radiating to upper left jaw, pain scaled 6/10 intermittent pain noted. Vital signs 100/60, P-69, O2 - 99%, RR-17. Patient given an ice pack to apply over the painful area. Pt verbalizes relief of pain. 20 mins after ice application > relief of pain noted and with reported pain scale of 3/10. Patient went home with relief of pain, reported pain scale 0/10 and stable vital signs, no dizziness, or headache noted. Vital signs BP 112/66, P-62, RR-18, 02 sat 99%
Local reaction, redness, swelling tenderness at the site of injection on Lt. deltoid region. 5" x 4".
Swollen at the site of injection; Left arm was slightly pink and had oval redness of 5in in height and 3in width; Little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore). At the time of the report, VACCINATION SITE SWELLING (Swollen at the site of injection), VACCINATION SITE ERYTHEMA (Left arm was slightly pink and had oval redness of 5in in height and 3in width) and VACCINATION SITE PAIN (Little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old  female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose,  for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications  included macrogol 3350 (MIRALAX) and  losartan potassium (LOSARTAN POTASSIUM) 25 mg.  Historical Vaccine includes  BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00,  Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date,  electrocardiogram: unknown results on an unknown date, Scan of head and stomach  unknown results on an unknown date and  vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
1/22 sneezing, runny nose, achy, chilling, temp about 100, diarrhea on/off, fever peaked 102 on 1/25/12, productive cough, temp decreasing to 100 1/28, feeling much improved 2/8/12.
This spontaneous report was received from a physician concerning a female patient of unknown age. Approximately on 24-MAY-2012 (reported as exactly one year ago), the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 23-MAY-2013, the patient was vaccinated with the second dose of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Pt originally seen for wcc, but was changed to sick visit being seen for cold s/s ongoing for 1 week. No fever reports. Pt and mom reporting that pt still wants Gardasil shot today. Pt given the shot, and was released after approx. 8-10min. Pt went to lobby to check out. A medical emergency was called. Pt was extremely pale, in the process a syncope episode.  Pt fully recovered and went home.
PATIENT HAD MIGRAINE HEADACHES AND NAUSEA W FLU-LIKE SYMPTOMS AND DIARRHEA FOR 5-7 DAYS. ALSO HAD REACTION TO FIRST VACCINE SIMILAR AND NOT REPORTED UNTIL SECOND VACCINE.
Area of arm near the site of injection became red, swollen and warm and tender to touch about 24 hours following the injection. Symptoms worsened for the next 24 hours before starting to subside. Patient took 180mg fexofenadine the evening the redness was noticed (14 April 2021). Pt reported event to PharmD on 16 April 2021, and stated the symptoms are better now than they were on 14 April.
About 10-11 days after vaccine, my arm was sore again and I broke out with a red, angry, splotchy, patch.  A little itchy, a little sore, about 3" in diameter.  Did some internet searching and saw it might be "Covid Arm", no reason to worry, and no reason not to get second shot which I'm scheduled for on the 18th.  Might use the right arm though since it's still a little warm and sore.
I95.9 HYPOTENSION 1/4/2023 DM 2 W CATARACT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/3/2023 DM 2 W CATARACT
Nausea Muscle aches and cramping Back and chest pain Headache Swelling and itching at injection site Low grade fever Chills   Beginning 02/15 and continuing today: 02/16/2021
This spontaneous report was received from a technician and refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 29-JUL-2016, the patient was vaccinated with her first dose of GARDASIL 9, lot # M007764 with expiry date 30-JAN-2018 (dose and route of administration were not reported). Subsequently, the patient received the second dose of GARDASIL 9 on 06-JAN-2017, lot # M007764 with expiry date 30-JAN-2018 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
unconsolable crying > 3 hrs; vomiting p/vax; recvd vax 29DEC93;
Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep.  After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.
Varicella immunization requested, HCP advised Shingles vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Shingrix. On 29-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: Varicella immunization requested, HCP advised Shingles vaccine). The outcome of the drug use for unapproved indication was unknown.   Additional Information: GSK receipt date: 29-Mar-2023 The patient received a dose of Shingrix on the day of reporting, but the company said this did not meet the requirement for varicella. The patient asked that was this correct. The patient was trying to understand if Shingrix vaccination was equivalent to Varicella vaccination. The patient stated that his/her physician led him/her down the wrong path. The patient did not mind to had the shingles vaccine, as he/she was not far from 60 years old. This just did not meet the requirement of the company vendor requirements. The patient did not want to went down that path until he/she communicate with his/her physician.  The patient stated that he/she will should had consulted with his/her daughter (who was a pharmacist). If the patient was not satisfied with the physician's response, he/she would then reach out to contact the safety department. The follow-up could not be possible as no contact details were available. The patient had to have the Varicella immunization, but the patient's physician said he/she should just do the shingles vaccination and received a dose of Shingrix on the day of reporting, but the company said this did not meet the requirement for varicella, which led to drug use for unapproved indication.
Swelling and a lot of pain in the underarm area; Swelling and a lot of pain in the underarm area; The patient previously received COVID-19 VACCINE MODERNA and then third (booster) dose of BNT162B2; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Dec2021 at 14:00 (Lot number: unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergic reaction to analgesics" (unspecified if ongoing), notes: Known allergies: Narcotics/opioids and "Drug allergy" (unspecified if ongoing), notes: Known allergies: Narcotics/opioids. Concomitant medications included: IBUPROFEN. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 11:00), administration date: an unknown date in May2021, when the patient was 40 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: an unknown date in Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Dec2021 at 14:00, outcome "unknown", described as "The patient previously received COVID-19 VACCINE MODERNA and then third (booster) dose of BNT162B2"; IMMUNISATION (non-serious) with onset 14Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 15Dec2021, outcome "not recovered", and all described as "Swelling and a lot of pain in the underarm area". Therapeutic measures were not taken as a result of swelling and axillary pain. Additional Information: It had been 52 hours since receiving the injection and pain and swelling persisted. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination was reported as may be Ibuprofen, but not sure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Parent voice the day after the injection her daughter had erythema around the njection site on R deltoid with warmth. Tha erythema it's aprox. 10 cm of diameter.
Rash/Hives within 2 hours of vaccine administration.  Rash/Hives reappeared the next day.
PTS PARENT REPORTS NOT NOTICING REACTION UNTIL LATE AT NIGHT ON 7/20/11 WHEN BATHING PT. STATES LED WAS SWOLLEN AND RED WITH RED RASH AROUND SITE AND DOWN LEG, SITE WAS WARM AND TENDER. THEY TOOD PT TO ER IN CASE IT WAS A DANGEROUS SPIDER BITE, ETC. ER RECORD STATES PROBABLE LOCAL REACTION TO IMMUNIZATION, BACTRIM PER ER DOCTOR. RASH AND SWELLING ARE RECEDING.
Injection site bumpy; Injection site Itching like crazy; Injection site super red; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE MASS (Injection site bumpy), VACCINATION SITE PRURITUS (Injection site Itching like crazy) and VACCINATION SITE ERYTHEMA (Injection site super red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thrombocytosis.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (Injection site bumpy), VACCINATION SITE PRURITUS (Injection site Itching like crazy) and VACCINATION SITE ERYTHEMA (Injection site super red). The patient was treated with CIPROFLOXACIN (BACTIN [CIPROFLOXACIN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Injection site bumpy), VACCINATION SITE PRURITUS (Injection site Itching like crazy) and VACCINATION SITE ERYTHEMA (Injection site super red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicine includes high blood pressure medicine and a pill (because they have too many platelets). Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
No additional AE; Medical Assistant called to report that an 18 month old was mistakenly given VARIVAX and PROQUAD at the same time. Caller stated patient has not had any side effects at this time. No additional AE/no PQC.    Dr. , okay to contact; This spontaneous report was received from a medical assistant referring to a 18-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 07-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (doses, routes of administration, lot numbers and expiration dates not reported) for prophylaxis (extra dose administered). No adverse event were reported.
Pt's left shoulder became hot, red and swollen approx. 20 hours after receiving vaccine. Pt's mother instructed per MD, to apply warm compress, elevate arm and give Tylenol.
12-36 hours after: mild fever, chills, severe fatigue unable to work or perform normal activities 36h-3 days after: mild-moderate fatigue, able to work but not at full capacity 3-6 days after: lymph node (axillary and in the neck) swelling and moderate to severe pain, unable to lift objects more than 10 lbs or perform normal weight bearing exercise. Working but with modifications. 7th day after: odd cramping and myalgias lasting 1-10 minutes in quadriceps, triceps, pectoralis muscles, flank, and upper back areas. 8-9 days: no symptoms 10 days to current time, day 13: systemic hives (scalp, face, neck, axillary, anterior forearms and antecubital spaces, palms, trunk circumferentially, groin and buttocks, posterior knees. Unable to perform daily functions, relying heavily on diphenhydramine, unable to work, visit to MD on 3rd day of hives and steroidal treatment (prednisone 60mg X2 days, 40mg X4 days, and 20mg X4 days) initiated with hydroxazine 10-50mg q8h prn for itching. Some moderate improvement in symptoms noticed 12 hours post steroidal treatment.  Notable on day 10, heavy workout with sweating, use of a new brand of coconut oil soap (with no hx of soap sensitivities), but hives began prior workout and use of soap.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.