Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, SARS-CoV-2 test, Swelling
Clinical narrative: severe headaches; strong pain in my head, my left arm and left eye; strong pain in my head, my left arm and left eye; light pressure during the morning in my head not as severe as the other days; whole body turned red; bumps; itchy; nausea; stomach ache; eyes were numb; left arm was numb; rash all over his body; chills; flu symptoms; Caller (male, age 33) spoke already to someone prior to Pfizer and gave information on his experience with the Pfizer covid vaccine.  "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad.  It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction.  I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?"  I had a side effect after the first dose of the vaccine.  Should I get the second dose?  e-transmitting potential duplicate AE. Caller said he didn't give PCP information to the safety agent. He did not have. Response: Spoke from EUA PI (Revised: 06 April 2021) under Post Authorization Experience Fact Sheet for Recipients and Caregivers (Revised: 06 April 2021) under section WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.    Request Name:  Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine.  "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad.  It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction.  I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?"  Caller wanted to know if his reactions could be due to him having covid before and if it was safe to get the covid vaccine after having covid infection. Response: Spoke from EUA PI (Revised: 06 April 2021) CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19.  Spoke from attached document and emailed as requested.  Request Name:  Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine.  "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad.  It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction.  I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?"  Caller wanted to know about delaying his second dose; information on timing of dose 2. Response: Spoke from attached document and emailed as requested.  Request Name:  Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine.  "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad.  It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction.  I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?"  Caller wanted to know about using Benadryl during/after the second dose. Response: Spoke from attached document and emailed as requested.  Request Name:  Product: PFIZER-BIONTECH COVID-19 VACCINE Caller (male, age 33) spoke already to someone prior to Pfizer MI and gave information on his experience with the Pfizer covid vaccine.  "I took the first dose of the Pfizer vaccine on Saturday 17APR2021. I got a severe reaction from the Pfizer vaccine. I got the normal chills the next day and flu symptoms. From the next day to day 5 I got severe headaches, strong pain in my head, my left arm and left eye. I took Tylenol and ibuprofen within those days. The Tylenol didn't help at all, ibuprofen 200mg didn't do much. Yesterday I went to the ER because I had light pressure during the morning in my head not as severe as the other days, in the afternoon I had a tight pressure in my head so I took 2 tablets of extra strength Tylenol, the headache went away but within an hour I had a bad reaction. My whole body turned red, bumps, itchy. It was bad.  It was bizarre because I've never had reaction to Tylenol prior. I never had that before yesterday. It was the first time. They gave me a shot of steroids. The doctor didn't know if it was a bad reaction to the Pfizer reaction (said it would usually occur within 4 hours of getting the vaccine) or the mix of the Tylenol and the pfizer vaccine together. He had no clue. But he had not seen a reaction of the vaccine at 5 days later. He said I could have reacted late, or the Tylenol and Pfizer vaccine together had a bad reaction.  I had covid late Jan of this year. The vaccine more interaction due to that if I had immunity to it. It was so bad I don't know if it's possible to wait 2 months for the 2nd shot. I heard the first dose 80-90 percent immunity or even more. With my body I never had this reaction. Today I'm a whole lot better (day 6). I am too putting too much, should I wait 90 days other say 4 weeks. What to do about the 2nd dose? How about using antihistamines during/after my second dose? What about Tylenol or Ibuprofen?"  Caller wanted to know about using Tylenol or ibuprofen. Response: Due his reaction informed caller to speak with HCP or allergist regarding this.   Follow-up #01 (23Apr2021): This is a follow-up spontaneous report received from a contactable reporter( patient). This male consumer (patient) reported that:  Narrative case summary and further information:  Patient Ethnicity: # Is the patient also the reporter? Yes  Reporter type: Consumer or other non health professional  Specify Consumer or other non health professional: self    Dates for massive severe headache: (From: Unspecified To: Unspecified)  Reporter seriousness for massive severe headache: Unspecified  Dates for had chills: (From: Unspecified To: Unspecified)  Reporter seriousness for had chills: Unspecified  Dates for nausea: (From: Unspecified To: Unspecified)  Reporter seriousness for nausea: Unspecified  Dates for little bit of a stomach ache and nausea: (From: Unspecified To: Unspecified)  Reporter seriousness for little bit of a stomach ache and nausea: Unspecified  Is Pfizer Vaccine a Pfizer product? Yes  Pfizer Vaccine manufacturer: Unspecified   Dates for Pfizer Vaccine: (Start: 17 Apr 2021 Stop: Unspecified)  NDC number of Pfizer Vaccine: Unknown  Expiry Date of Pfizer Vaccine: Unknown  Why was the patient taking Pfizer Vaccine (Verbatim): just to get vaccinated for covid  Other Products: No  Patient History: No  Investigation Assessment: No  Additional Context:  Caller states he is calling about the Pfizer Vaccine and has a couple of questions in his experience with this; states he had the 1st dose of the Pfizer Vaccine on 17Apr2021 and had a really severe reaction with it and basically through the next day he had normal things that are normal but the last 5 days he has had a massive severe headache and overnight had chills then his symptom was  nausea and headache and everything else; states the following four days after that he had a little bit of a stomach ache and nausea which were not as bad but had a severe headache.   States he had a severe body reaction on Thursday 22Apr2021 and today he is 100 percent better.   HCP information: Caller declined to provide the HCP information as he does not have that with him at this time.  States he took Tylenol yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on  the 2nd day Sunday 18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207.  States the emergency room gave him a steroid shot he can't find the name of and has no dosage, lot number to provide.  States the emergency room gave him a medication Prednisone that he is to take for the next 5 days and is required to take it this  week and it is 5mg in an orange pharmacy bottle with no lot or expiry date because it is an orange pharmacy bottle.  States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713.  States the Tylenol and Ibuprofen were the two ones that were recommended to take and he took them and the Tylenol and Ibuprofen  gave him a severe headache and it was really really bad on the 5th day which was yesterday and the pressure from the headache he  could feel and it was a slight pressure and was uncomfortable and the left side of his body and his eyes were numb and the left arm  was numb; states after that the next day on the 5th day, he had a tight pressure in his head and in late afternoon the pain was starting  to get tighter with a severe headache; states today is the 6th day.  Caller states he took Tylenol again and a half hour later he had a severe body rash all over his body and had to go to the emergency room to get a steroid shot from it and the rash is not ongoing and he went to the ER yesterday and they have him the steroid shot at  that time and a medication to take for the next 5 days which caller said is the Prednisone.  States he had the really bad rash all over his body and it was really really red and itchy and he had bumps coming up so went to the  emergency room and they could not tell if it was due to the Tylenol or part of the Pfizer Vaccine; states he had taken Tylenol a couple  of times in 5 days and was fine and then took Tylenol yesterday and had the severe reaction.  States he had been reading a lot and is really worried about taking the 2nd dose of the Pfizer vaccine and is debating on waiting two  months before getting the 2nd one and his general practitioner can't find anything wrong and can't say the reported event is due to  the Pfizer Vaccine; states a lot of people get a reaction in 6 days he has found in his reading; states his HCP has some patients that  had reactions within 4 hours and not in 5 days after the vaccine and states he has no patient information or lot numbers for their  vaccines to report.  States he had covid in late January 2021 and that can react a lot with the Pfizer Vaccine and he understands that and does not know  if this is actually an allergy of the vaccine in these few days of the last 7 days or if is the Tylenol reacting with the vaccine. States he  realized that having had covid in late January could affect him a lot more with the vaccine. Caller states he only has the medication  for Prednisone that he was given to take for the reaction from yesterday.  VACCINE SUPPLEMENTAL FORM  Patient Age at Time of Vaccination in Years: 33  Vaccine Lot Number: EW0162  Time the Vaccination Was Given: 10:35am  Vaccine Lot Expire Date: unknown  Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm  History of all previous immunization with the Pfizer vaccine considered as suspect: This was the 1st dose of the Pfizer vaccine  administered on 17Apr2021.  Additional Vaccines Administered on Same Date of the Pfizer Suspect: None  Did any AE(s) require a visit to ER or MD office?: Yes, emergency room but not the HCP office.  If the patient was hospitalized, how many days was the hospital stay?: n/a  Prior Vaccinations (within 4 weeks): None  Patient's Medical History: see additional context  Family Medical History Relevant to AE(s): None  Relevant Tests: None   PSCC Communication: PC filed. Caller was provided with the report reference number, contact information and hours of operation for  Covid Line, #  option #3, Monday to Friday 8:00am to 8:00pm EST and Saturday and Sunday 9:00am to 3:00pm  EST; caller was placed on hold; due to larger than normal call volumes, the caller agreed to be placed into the queue for the  next available agent.   Is there a Product Complaint: Yes  Description of Product Complaint:  Description of complaint: Vaccine Supplemental Form completed in additional context. Caller states he is calling about the Pfizer  Vaccine; states he had the 1st dose of the Pfizer Vaccine and had a really severe reaction with it;States he realized that having had  covid in late January could affect him a lot more with the vaccine. States he had covid in late January 2021 and that can react a lot  with the Pfizer Vaccine and he understands that and does not know if this is actually an allergy of the vaccine in these few days of the  last 7 days or if is the Tylenol reacting with the vaccine.States the Tylenol and Ibuprofen were the two ones that were recommended  to take and he took them and the Tylenol and Ibuprofen gave him a severe headache and it was really really bad on the 5th day  which was yesterday and the pressure from the headache he could feel and it was a slight pressure and was uncomfortable and the  left side of his body and his eyes were numb and the left arm was numb; states after that the next day on the 5th day, he had a tight  pressure in his head and in late afternoon the pain was starting to get tighter with a severe headache.States he took Tylenol  yesterday and the whole week which is Tylenol Extra Strength 500mg and yesterday took two tablets and on the 2nd day Sunday  18Apr2021 he took about 5 tablets the whole day and the bottle has expiry date 2024 and lot ABC207.  States he took Ibuprofen 200mg with expiry date Dec2022 and lot WJ02713.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on Jan2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable. This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:35 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills (chills) (medically significant) on 18Apr2021 with outcome of unknown , flu symptoms (influenza) (medically significant) on 18Apr2021 with outcome of unknown , severe headaches (headache) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (pain in extremity) (medically significant) on an unspecified date with outcome of unknown , strong pain in my head, my left arm and left eye (eye pain) (medically significant) on an unspecified date with outcome of unknown , light pressure during the morning in my head not as severe as the other days (head discomfort) (medically significant) on an unspecified date with outcome of unknown , whole body turned red (erythema) (medically significant) on an unspecified date with outcome of unknown , bumps (swelling) (medically significant) on an unspecified date with outcome of unknown , itchy (pruritus) (medically significant) on an unspecified date with outcome of unknown , nausea (nausea) (medically significant) on an unspecified date with outcome of unknown , stomach ache (abdominal pain upper) (medically significant) on an unspecified date with outcome of unknown , eyes were numb (hypoaesthesia eye) (medically significant) on an unspecified date with outcome of unknown , left arm was numb (hypoaesthesia) (medically significant) on an unspecified date with outcome of unknown , rash all over his body (rash) (medically significant) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on Jan2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.