chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care professional concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-OCT-2016 at 16:00, the patient was vaccinated on her right arm with a first dose of PNEUMOVAX 23 (lot # M038216), (strength, dose, route and expiration date were not provided) for prophylaxis. The patient did not have any illness at the time of vaccination. On 27-OCT-2016, one day post vaccination, the patient experienced inflamed and raised around the injection site described as the size of a tennis ball (injection site inflammation), and also she experienced redness and itching which was advised her to take BENADRYL. At time of the report, the patient had recovered from the events. The causality between the events and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Arm soreness for <24hrs immediately after injection with no further s/s until 1 week later when presented with localized allergic rxn- swelling, erythema, itching, heat to deltoid area apreading down to bicep over the next 24hrs. Treated with daily low dose benadryl x 4 days so far with decreased s/s
Information has been received from a pharmacy purchaser concerning a senior citizen pt (age and gender not specified) who was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic. On an unspecified date, recently, the pt developed severe pain at the injection site, so much so that the pt could not sleep at night. It was also reported that the pt had swelling present. It was unk if the pt sought unspecified medical attention. At the time of the report, the outcome of the events were unk. Additional information is not expected.
Normal flu like symptoms 12 hours after vaccination.  24 hours after vaccination severe headache, severe nausea, dizziness and shortness of breath.  Redness and swelling and itching at vaccination site. Rescue was called and vital were normal by the time they arrived. 50 mg Benadryl given.
Reported feeling hot and itching.  Pt was flushed and itching chest and arm. No swelling/tightness/ tingling in mouth or throat.  Pt vitals:  17:35- hr 102, bp 160/110,  O2sat: 96 Pt given 50mg Benadryl IM 17:45- hr 86, bp 140/90,  O2sat: 96 R: 18 decrease in flushing and itching 18:15- hr 78,  bp 138/85,  O2sat: 98   18:15 pt released. Recommended she continue to monitor for symptoms. Told her she can take oral Benadryl at home. Told pt to call 911 with any difficulty breathing, increased hr or severe illness. Recommended she notify her MD of the reaction and that she could not get the second dose of  mRNA COVID vaccine.
pain at injection site; chills; fatigue; nausea; dizziness; sore throat; bad cough; lymphadenopathy; lost her taste; lost smell; Feeling bad; unable to go to work; This is a spontaneous report from a contactable consumer received from Pfizer Sponsored. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Started to feel bad on 07Apr2021 now she was unable to go to work symptoms include coughing, chills, pain at injection site, nausea the first 2 days, dizziness, sore throat, bad cough and lymphadenopathy. She also lost her taste and smell. She was scheduled for her second dose on 24Apr2021 and it was wondering if she should still get the second dose or if she should wait. She and her son took the vaccine the same day and he was not showing any adverse effects. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning a patient who on 30-NOV-2005 was vaccinated with a dose of VARIVAX (Merck) (647538/0784R) subcutaneously in the left arm. On 01-APR-2008 the patient experienced rash on torso/back and papular vesicles. No crusting yet. No illness at the time of vaccination. Additional information has been requested.
pain on the upper part of her right ear which extended to her right eye; dizziness; heart palpitations; bad bruise on her left arm where the vaccine was administered; pain on the right side of her head and the upper part of her right ear which extended to her right eye; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054(?)C21A) for COVID-19 vaccination.     No medical history is provided by reporter.     On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, EAR PAIN (pain on the upper part of her right ear which extended to her right eye), DIZZINESS (dizziness), PALPITATIONS (heart palpitations), VACCINATION SITE BRUISING (bad bruise on her left arm where the vaccine was administered) and HEADACHE (pain on the right side of her head and the upper part of her right ear which extended to her right eye) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant drugs were not provided
Muscle soreness in shoulder/upper arm where vaccine was given. Can only lift arm halfway up. It goes away for a little while during the day if patient works out but will be very sore in the morning after sleeping all night.
Following 15 minutes of monitoring after receiving the COVID19 vaccine, the patient experience dizziness upon standing and reported tingling in lower limbs.  Patient was monitored for an additional 20 minutes and symptoms resolved.  Patient had no other complaints.
25 minutes after his injection stating he had felt a full flush sensation throughout his body, increased heart rate with palpitations, metallic taste, and was visibly shaking. Vitals taken BP 110/74, 99.0 oral temp, 97% o2, HR range from 74-78. Evaluated by PA-C
(L) deltoid area red swollen area 110 mm x 70 mm with induration
UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included tiredness, and sleeping a lot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced unexpected benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.
22 y.o M with generalized eruption on torso & prox extremities developed 4d after smallpox vaccination. Red papules, some follow lines of cleavage with some central scale. Diagnosis with Pityriasis Rosea like rxn to vaccinia vaccine Tx with Emycin 250mg qid, F14 TAC 0.1% Prn or bid; Zyrtec 10qd, Atarax 50-75mg qhs.
was diagnosed with Covid with no symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jun-2021 and was forwarded to Moderna on 30-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported
Patients entire arm swelled (from shoulder/back to wrist.  The arm was hot to the touch.  Patient was irritable and found his arm very painful.  Motrin and Benadryl were given to ease discomfort.
Vertigo; Tingling in legs; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and PARAESTHESIA (Tingling in legs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included Vertigo (Resolved.) in 2016.   On 16-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 13-Jan-2022, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2022, the patient experienced VERTIGO (Vertigo). In 2022, the patient experienced PARAESTHESIA (Tingling in legs). At the time of the report, VERTIGO (Vertigo) had not resolved and PARAESTHESIA (Tingling in legs) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.
Td given 30Jul04. Redness and pain occurred on site of injection. Time of reaction unknown. Treated with Benadryl 50mg IM.
IPOL was given to a child in the arm and the child pulled the arm away and only received half the dose (with no reported adverse event); Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Child and unknown gender patient to whom IPV (VERO) [IPOL] was given in the arm and the child pulled the arm away and only received half the dose (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO), suspension for injection (dose, strength, lot number and expiry date not reported) via unknown route in arm Nos for immunization and the child pulled the arm away and only received half the dose (with no reported adverse event) (incorrect dose administered) (unknown latency). Caller is wanted to know if they should re administer.  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Did not receive 3rd dose till the time of reporting; 1st dose on 6/14/2021, 2nd dose on 7/26/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26th July 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, unknown after starting Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 4-May-2022 Reporter's comments: The pharmacist would like to know if the patient could receive the third dose of Twinrix on the date of reporting. The patient received 1st dose of Twinrix on 14th June 2021. The patient received 2nd dose of Twinrix late on 26th July 2021. During the call, the third dose was not given yet. The healthcare professional had intention to do it but at the moment of the consult by phone, the vaccine had not been administered. The consent to follow up was given by postal or email address, however the healthcare professional requested by phone Additional Supportive Information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to which led to lengthening of interval between vaccine doses. Till the time of reporting the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Red swollen arm; Localised erythema; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PERIPHERAL SWELLING (Red swollen arm), ERYTHEMA (Localised erythema), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The treatment medication was not provided.
I had a very ,very bad back pain ,i couldn't move started 3/4 hours after vaccine
Patient started with right upper thigh redness & swelling and started complaining of pain and itchiness. Parent drew a circle around the patient's redness/swelling of the right upper thigh around 5:00pm 7/31/2021. Parent was treating with oral Benadryl and topical Benadryl as directed on the box, and has trialed icing the site. The patient has had no relief from the itching and swelling. The redness and swelling has continued outside of the circle which prompted the parent to bring the patient into clinic on 8/1/2021. Dr. determined it to be a local reaction to immunization, and recommended to continue to cold compresses 3-4 times daily, and continue oral Benadryl 15mg 3-4 times daily, with the use of Tylenol 160mg/5ml as needed for pain every 4-6 hours. Dr. marked the new site of redness and swelling and the patient is to notify the provider's office if any worsening in redness/swelling.
p/vax pt devel cellulitis, h/a, eye pain required oral ATB, pain & eye medication;
Starting about 8 hours after the vaccine injection, I started having every side effect that was listed...shivering, fever, headache, nausea, trouble breathing, body aches, writhing in pain, didn't sleep the whole night, foggy, injection site severe pain, itching, jaw and mouth pain, weakness, extreme tiredness and exhaustion. I was told I'd have a few of these side effects for a day or two, three days at the most but I suffered from them for one week!!! Two weeks went by and then I got a bad cold or sinus type infection which is three days in and still not going away. Might this have to do with the SHINGRIX vaccine side effects delayed effects? I've never had issues before and this was and is very scary.
Walking out of the office - she fainted, her arm and left leg were stiff, needed oxygen, and was very gray/white in color.
Information has been received from a physician and a mother concerning her son who on 13-OCT-2009 was vaccinated with the third dose of ROTATEQ (Lot No. not provided) that had expired on 25-SEP-2009.  The mother reported that her son also received several unspecified vaccines at the same time as ROTATEQ and that her son had a
NA from Rehab called RN (on her cell phone) on 7/9/21 to report this patient had an AE 1.5 hours after receiving her Pfizer COVIC vaccine.  Patient had SOB and increased anxiety.  Her 02 sats dropped in to the 80s.  Her MD was alerted and he ordered O2 at 2 liters, benedryl and constant O2 monitoring.  Pt was given her usual Lorazapam and Hydroxazine for anxiety and appeared  increasingly anxious.  Pt. was monitored continuously until symptoms subsided on 7/10/21.  She was then back to baseline.  RN followed up with facility and reported this AE on the website.
Approximately 18 hours after receiving vaccine experienced facial swelling including lips and tongue. Initially treated with Benadryl  from 01/10/20 through 01/15/20. Swelling improved but did not completely resolve. 01/20/21 swelling increased to involve lips, tongue, and throat. Treatment initiated with Methylprednisolone 4mg taper pack and Benadryl. Symptoms waxed and waned throughout treatment course, never resolving. Recommended by physician on 01/25/20 to take Pepcid twice daily and Benadryl every 6 hours. Still undergoing treatment and experiencing symptoms that wax and wane.
Heart was beating away fast; Lost a lot of weight; Really bad heartburn; Can't hardly eat; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient (in his 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose (1st dose, single dose), with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's was beating away fast; had lost a lot of weight; had a really bad heartburn; and could not hardly eat. The patient was hospitalized on an unspecified date due to the reported events. The outcome of the events was unknown. The patient stated she would not be taking the second dose of vaccination.  Information on the lot/batch number has been requested.
the adverse event its a error on administration. Patient comes to the clinic for her 4th dose (2nd booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine (0.25 ml administered) , the administered vaccine doesn't present any previous temperature excursion or any related problems.
The patient received the vaccines in the same arm because she had an injury in the left arm. That day she felt nauseous and started to throw up and her right arm became very red and inflamed. She stated she had a slight fever.
I received the flu vaccine.  My arm was red, swollen, warm to the touch and itchy only on the injection site.  It remained this way for 4-5 days.  However, my arm is still a little itchy and it has now been 7 days since vaccination.
Client verbalized feeling a sudden rush of warmth from her stomach to her chest. Onsite paramedics evaluated client.  Client was observed for 15 additional minutes.  Vital signs BP 124/2, O2Sat 100%, HR 96.  Per paramedics client will not need any further evaluation.  Client exited facility at 12:40pm.
Extreme fatigue, exercise intolerance. Needing to stop and rest/lay down doing normal daily activities. Very sore and tender breasts and nipples (both sides)  for 5 days after the shot. Period was brought on early and heavier than normal. Have gained a total of 7 lbs since the date of the shot ( my weight is always steady)  Experience severe pain in my stomach any time I eat, severe bloating in the stomach especially upper GI and some heartburn. Bowel movements slowed/infrequent for the first few days ( I always have a bowel movement each morning) then stopped altogether. Now needing to take miralax and stool softeners daily to have bowel movements. Constant feeling of an uneasy and unsettled stomach. These symptoms are keeping me up at night and affecting my sleep and daily life and have not eased up. I am extremely concerned as to what this has done to my body and if these will be long term. I contacted my gastroenterologist and he wants to see me if these symptoms do not subside by this week, with the way I'm feeling I don't believe they will.
Approx 4 hrs post vaccination, patient complained of centralized chest pain, headache- unlike migraines, pain in back, head feels  "swimmy".  BP: 136/106, P: 84, O2 Sat: 99% , R: 20.   16:40 BP: 137/97.  P: 72, R: 20.   16:45 Chest pain resolved, no N/V.  BP: 132/98. P: 70.  O2 SAt: 99%.  17:03 Headache and neck pain radiates to chest, feels like cramping, head swimming,  BP elevated again.  BP: 139/103.  P: 87.  O2 Sat: 99%.  17:05 EMS activated.  Patient transported to hospital via ambulance at 17: 25 for further assessment.
Pt felt lightheaded briefly. Has allergy to NSAIDS so gave juice and watched 30 minutes in car
Initial report received on 26 June 2009 from a health care professional. A female patient had received a dose of MENACTRA (lot number and route not reported) in the right arm on 22 June 2009. At an unspecified amount of time later, the patient developed adenopathy of the right axilla. Treatments received and diagnostic tests preformed were not reported. The reporter was unable to provide any other information. Recovery status was not reported. Follow up information was received on 03 Sep 2009 from a health care professional regarding an 18 year old female patient. Lot number for MENACTRA administered was U2636AA and the route of administration was intramuscular. The patient recovered from the event. No further information was provided. Documents held by sender: none.